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2012-2013 Influenza Vaccine Availability

October 23, 2012

2012-2013 Influenza Vaccine is available for immediate shipment. CDC recommends that influenza vaccination begin as soon as vaccine becomes available in the community and continue throughout the flu season. It takes about two weeks after vaccination for antibodies to develop in the body and provide protection against influenza.

Flu Outlook

According to “Flu View” on the CDC website, here is a synopsis of the Flu activity during week 41 (October 7-13, 2012), indicating influenza activity remained low in the United States.

  • Of 3,285 specimens tested and reported by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories during week 41, 129 (3.9%) were positive for influenza.
  • The proportion of deaths attributed to pneumonia and influenza (P&I) was at the epidemic threshold.
  • One influenza-associated pediatric death was reported and was associated with an influenza A virus for which the subtype was not determined.
  • The proportion of outpatient visits for influenza-like illness (ILI) was 1.1%, which is below the national baseline of 2.2%. All 10 regions reported ILI below region-specific baseline levels. Forty-eight states and New York City experienced minimal ILI activity and the District of Columbia and two states had insufficient data.
  • The geographic spread of influenza in one state (Iowa) was reported as local; the District of Columbia and 32 states reported sporadic activity; Guam and 16 states reported no influenza activity, and Puerto Rico, the U.S. Virgin Islands, and one state did not report.

For more information on the Flu Season or the Flu Vaccine please visit the CDC website at: http://www.cdc.gov/flu/keyfacts.htm

Vaccine Benefits

A flu vaccine is needed every year because flu viruses are constantly changing. It’s not unusual for new flu viruses to appear each year. The flu vaccine is formulated each year to keep up with the flu viruses as they change.

Also, multiple studies conducted over different seasons and across vaccine types and influenza virus subtypes have shown that the body’s immunity to influenza viruses (acquired either through natural infection or vaccination) declines over time.

Getting vaccinated each year provides the best protection against influenza throughout flu season.

CDC recommends that influenza vaccination begin as soon as vaccine becomes available in the community and continue throughout the flu season. It takes about two weeks after vaccination for antibodies to develop in the body and provide protection against influenza, and influenza seasons can begin as early as October and last as late as May. Therefore, CDC recommends that vaccination begin as soon as vaccine becomes available to ensure that as many people as possible are protected before flu season begins.

Orders

The manufacturer of the 2012-2013 Influenza Virus Vaccine SSC contract is Fluvirin® from Novartis. Please note that Fluvirin® is for ages 4 years and older. The vials are not preservative free, they contain a very small amount of thimerosal (25 mcg), unlike the prefilled syringes which are preservative free.

INFLUENZA VIRUS VACCINE 2012-2013

NSN

Product Description

U/I

Price

6505-00-00-7925

0.5 ml Luer-Lok Prefilled Syringes, 10s Fluvirin® Preservative free

Syringes

$68.63

6505-00-000-7926

Multiple Dose 5 ml Vial (10 doses) Fluvirin®

Vial

$56.13

Needles recommended for use with the flu vaccine are:

  • 6515-00-000-0082 (23G X 1 in.), 50s Safety Glide
  • 6515-00-000-0081 (25G X 1 in.), 50s Safety Glide

Order / Contact Information

Orders can be faxed to (410) 642-0228, or called in to customer service at 1-800-642-0263 or to Annette Quiñones at 410-642-2244. If you have any questions or concerns please contact Customer Service or Annette Quiñones.

 

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Voluntary Recall of Typhoid Vaccine

October 10, 2012

As a precautionary measure, Sanofi Pasteur is voluntarily recalling 6 lots of Typhim Vi®, Typhoid Vi Polysaccharide Vaccine with potentially low antigen content.

This action was taken, in consultation with the US Food and Drug Administration, because of potential lower potency of the vaccine against typhoid fever due to a lower antigen content (ie, an antigen content below the official Pharmacopeia specification limit) in some lots of vaccine.

Please note:

  • There is no safety concern for the persons who received a Typhim Vi vaccine from a recalled lot.
  • Persons who received a Typhim Vi vaccination from a recalled lot may have received less than the intended amount of antigen. Although Sanofi Pasteur does not have clinical trial data on the immunogenicity and efficacy of Typhim Vi vaccine with antigen content below specification, Sanofi Pasteur does not recommend revaccination earlier than otherwise indicated based on existing dose-ranging data and knowledge of the kinetics of Typhim Vi vaccine.
  • Typhim Vi vaccine from lots not being recalled can be administered.

There are 5 lots of Typhim Vi vaccine prefilled syringes (NDC 49281-790-51) and 1 lot of 20-dose vials (NDC 49281-790-20) that are affected.

Lot Number

Expiration Date

NDC

UOM

E1287-1

20NOV12

49281-790-51

Prefilled Syringes

E1288-1

17NOV12

49281-790-51

Prefilled Syringes

G0481-1

07SEP13

49281-790-51

Prefilled Syringes

G0507-1

20SEP13

49281-790-51

Prefilled Syringes

G0508-1

27SEP13

49281-790-51

Prefilled Syringes

G1130-1

18MAR13

49281-790-20

20-Dose Vial


We ask for your cooperation in taking the following action:

  • Please examine your inventory immediately and if you have the recalled product in question immediately cease distribution/ use.
  • If you have purchased the product from SSC, fill out enclosed Return Response Form and send with recall.
  • Mark the returned product purchased from SSC “Recall Materials Enclosed,” and return to:
    ATTN: Quality Assurance
    HHS Supply Service Center,
    Building 14,
    Perry Point, MD 21902
  • Open containers are not accepted for credit.

Return the affected product before November 30th 2012 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product. Please note customers must reorder the Typhoid Vaccine.

Contact

If you have any questions about this recall, please contact John Diesel, Quality Assurance Specialist at 1-800-642-2244 Ext: 1128. We apologize for any inconvenience and appreciate your prompt attention to this recall.

 

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Ventolin HFA (albuterol sulfate) Inhaler Recall

August 03, 2012

GlaxoSmithKline is recalling the Ventolin HFA Inhaler from the wholesale and retail level. The lots listed below are being recalled due to a potential for the content of albuterol per dose to be below specification.

Ventolin HFA (albuterol sulfate) Inhaler
Product Description NSN NDC Lots Exp. Date
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP7355 Dec. 2012
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP7749 Jan. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP8141 Jan. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP8147 Jan. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP7729 Jan. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP0414 Mar. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP0464 Mar. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP0570 Mar. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP0576 Mar. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 1ZP0919 Mar. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 2ZP4959 Apr. 2013
Ventolin HFA Inhaler 6505-01-543-6534 0173-0682-20 2ZP4966 Apr. 2013
 

This product was shipped between September 12, 2011 and May 4, 2012

Stop distributing and immediately quarantine all listed Ventolin HFA Inhaler lots.

Contact

Contact Stericycle to establish a credit account at 1-888-943-4202. They will send you a returns authorization packet which must be filled out and sent back to Stericycle with the recalled product. Reimbursement will be issued at the price in effect at the time of return. In addition, reimbursement will also include a service and handling payment based on the HDMA guidelines.

If you have any question please call David Wernek, Quality Assurance Specialist at 410-642-2244 ext.1130.

 

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2012-2013 Influenza Virus Vaccine Ordering Procedures

May 1, 2012

The Supply Service Center has commenced taking orders for the 2012-2013 Influenza Virus Vaccine. All ordering activities are advised to consolidate their requirements for the 2012-2013 flu season and place their orders as soon as possible so we can better plan to meet customer needs.

INFLUENZA VIRUS QUADRIVALENT VACCINE 2012-2013

NSN

Product Description

U/I

Price

6505-00-00-7925

0.5 ml Luer-Lok Prefilled Syringes, 10s Fluvirin® Preservative free

Syringes

$68.63

6505-00-000-7926

Multiple Dose 5 ml Vial (10 doses) Fluvirin®

Vial

$56.13

 

Safety needles recommended for use with the flu vaccine are:

  • 6515-00-000-0082 (23G X 1 in.), 50s Safety Glide
  • 6515-00-000-0081 (25G X 1 in.), 50s Safety Glide

The Supply Service Center has commenced taking orders for the 2012-2013 Influenza Virus Vaccine. All ordering activities are advised to consolidate their requirements for the 2012-2013 flu season and place their orders as soon as possible so we can better plan to meet customer needs.

We request requirements for this vaccine be submitted as a separate purchase order since orders will not be processed until stock is available. Additionally, no orders will be processed unless accompanied by the appropriate purchase information. Notification of any address change or hours of operation need to be confirmed before delivery. We encourage all customers to fax their orders to (410) 642-0228 or contact customer service at 1-800-642-0263 or 410-642-2244.

At this time, delivery to SSC is expected to be within the 1st week of September. Please note, this delivery schedule is subject to change and is at the discretion of the manufacturer. We will advise our customers of any change in the delivery schedule, if any, when we are notified.

The manufacturer of the 2012-2013 Influenza Virus Vaccine SSC contract is Fluvirin® from Novartis. Please note that Fluvirin® is for ages 4 years and older. Please notify us if you have patients younger than 4 yrs. that require vaccination.

Contact

If you have any questions or concerns please feel free to contact Annette Quinones at (410) 642-1386 or annette.quinones@psc.hhs.gov.

 

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New Temperature Indicator Program

April 24, 2012

SSC has always strived to excel in customer service and provide you with news of any upcoming innovations or changes. So to better serve you, we have implemented a new temperature indicator program. The SSC TransTracker® CF that we will be shipping out soon to you with your refrigerated shipment is required to stay within an acceptable temperature range.

We have included this dual temperature indicator (SSC TransTracker® CF) to determine if your product has either exceeded or went below a specific temperature range. Please follow the steps below to confirm that your product has not gone out of the temperature ranges set by the manufacturer when you receive your refrigerated products.

transtracker-cf

Step 1: Check Temperature Limit

If the dot on this indicator is white like the example on the left, your product is OK. If the dot on this indicator is red, please call customer service at 1-800-642-0263.

transtracker-cf1

Step 2: Check FREEZEmarker

If you can see the check mark, as in the example to the left, your product is OK. If you cannot see the checkmark, please call 1-800-642-0263.

 

Contact

If you have any questions or concerns, contact Annette Quinones via Annette.Quinones@psc.hhs.gov or 410-642-1386.

 

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Crickit® Kit Component Recall

February 21, 2012

Under the direction of the FDA, North American Rescue, LLC (NAR) announces Febuary 6, 2012 the market recall of the NAR Surgical Crichothyroidotomy Kit or Crickit®, due to potential contamination of the povidone iodine prep pads, manufactured by Triad Group.

According to the recall conducted by Triad Group, the prep pads may be contaminated with the bacterium Elizabethkingia meningoseptica, which could potentially result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

This recall is a follow up to the recall initiated on May 5, 2011.

The Crickit® Kit component may be found inside a larger kit, the NAR Medic Trauma Pack Kits, available in 4 colors for which the codes are listed below. Only the Crickit® component is being recalled. This product has been discontinued and therefore is no longer included in the Medic Trauma Pack Kits.

Product Code Item Description NSN
1.) 10-0017 Surgical Cricothyroidotomy Kit or Crickit 6515-01-540-7568
2.) 80-0070 Medic Trauma Pack Kit – BLK (Black) 6545-01-572-7251
3.) 80-0071 Medic Trauma Pack Kit – ODG (Green) 6545-NS1
4.) 80-0072 Medic Trauma Pack Kit – COY (Tan) 6545-01-588-1862
5.) 80-0096 Medic Trauma Pack Kit – DUC (Camouflage) 6545-NS2
 

(1) 10-0017 Surgical Cricothyroidotomy Kit or Crickit®
Lot No(s): 21096, 21420, 21421, 21422, 21423, 21424, 21910, 21911, 21912, 21913, 22151, 22152, 22289, 22290, 22344, 22345, 22346, 22347, 22725, 22726, 22727, 22728, 22946, 22947, 22948, 22949.

(2) 80-0070 Medic Trauma Pack Kit – BLK.
Lot No(s): 80-0070093009, 80-0070092810, 80-0070092210, 80-0070080609, 80-0070072810, 80-0070072710, 80-0070071510, 80-0070070710, 80-0070063009, 80-0070061710, 80-0070060110, 80-0070050409, 80-0070040910, 80-0070032211SX, 80-0070031210, 80-0070022211X, 80-0070021810, 80-0070020910, 80-0070012510, 80-0070012210, 80-0070011310, 80-0070120910, 80-0070120710, 80-0070112309, 80-0070111210, 80-0070102910, 80-0070102810, 80-0070102210, 80-0070101310, 80-0070100810.

(3) 80-0071 Medic Trauma Pack Kit – ODG.
Lot No(s): 80-0071092909, 80-0071090910, 80-0071090109, 80-0071072710, 80-0071071310, 80-0071041411SX, 80-0071012810, 80-0071012510, 80-0071120910, 80-0071102910.

(4) 80-0072 Medic Trauma Pack Kit – COY
Lot No(s):  80-0072092909, 80-0072092710, 80-0072090810, 80-0072090109, 80-0072083109, 80-0072082310, 80-0072081109, 80-0072081009, 80-0072080709, 80-0072050710, 80-0072050409, 80-0072042110, 80-0072041510, 80-0072041410, 80-0072031710, 80-0072012910, 80-0072012810, 80-0072012010, 80-0072110810, 80-0072101210, 80-0072100410.

(5) 80-0096 Medic Trauma Pack Kit – DUC.
Lot No(s):  80-0096061710, 80-0096050409, 80-0096041610, 80-0096031810, 80-0096012910, 80-0096012810, 80-0096012510, 80-0096010710, 80-0096120910, 80-0096120909, 80-0096112409, 80-0096110810, 80-0096101509, 80-0096101210, 80-0096100410.

We ask for your cooperation in taking the following action:

  • Please examine your inventory, and if you have the recalled product in question immediately cease distribution / use.
  • If you have purchased the product from SSC, fill out the enclosed Return Response Form and send with recall product.
  • Mark the returned product purchased from SSC “Recall Materials Enclosed,” and return to:
    ATTN: LESLIE RIDGEWAY
    HHS Supply Service Center,
    Building 14,
    Perry Point, MD 21902
  • Open containers are not accepted for credit.

Return the affected product before March 21, 2012 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product. Please note the Surgical Cricothyroidotomy Kit or Crickit® is no longer manufactured and cannot be reordered.

Contact

If you have any questions about this recall, please contact David Wernek, Quality Assurance Specialist at 1-800-642-0263. We apologize for any inconvenience and appreciate your prompt attention to this recall.

 

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Tetracycline HCI Capsules Recall

February 14, 2012

Teva Pharmaceuticals USA Inc. is voluntarily recalling all lots expiring through 11/2014 of Tetracycline HCI Capsules USP, 250mg and 500mg distributed under the Teva Pharmaceuticals label only. This recall is being carried out to the retail level and is due to the potential for foreign particulate matter in the API.

Description NDC NSN
(1) Tetracycline HCl Capsules USP, 250 mg, Unit Dose
(2) Tetracycline HCl Capsules USP, 250 mg, 100’s
00172-2416-00 / 00172-2416-10
00172-2416-60
6505-00-117-6147
(3) Tetracycline HCl Capsules USP, 250 mg, 1000’s
(4) Tetracycline HCl Capsules USP, 500 mg, Unit Dose
(5) Tetracycline HCl Capsules USP, 500 mg, 100’s
(6) Tetracycline HCl Capsules USP, 500 mg, 1000’s
00172-2416-80
00172-2407-00 / 00172-2407-10
00172-2407-60
00172-2407-80
6505-00-963-4924
 

We ask your cooperation in taking the following action:

  • Please examine your inventory, and if you have the recalled product in question immediately cease distribution / use.
  • If you have purchased the product from SSC, fill out the enclosed Return Response Form and send with recall product.
  • Mark the returned product purchased from SSC “Recall Materials Enclosed,” and return to:
    ATTN: LESLIE RIDGEWAY
    HHS Supply Service Center,
    Building 14,
    Perry Point, MD 21902
  • Open containers are not accepted for credit.

Return the affected product before March 14, 2012 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product. Please note customers must reorder the Tetracycline Capsules 250mg and 500mg.

Contact

If you have any questions about this recall, please contact David Wernek, Quality Assurance Specialist at 1-800-642-0263. We apologize for any inconvenience and appreciate your prompt attention to this recall.

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Eloxatin Recall

February 13, 2012

Sanofi-Aventis U.S. LLC is initiating a voluntary recall of twenty-five lots of Eloxatin 50mg and 100mg vials, to the retail level with the knowledge of the Food and Drug Administration.

These lots were manufactured at Ben Venue Laboratories, a contract manufacturer which has been identified by the Food and Drug Administration as having significant issues in Good Manufacturing Practices (GMP). There have been no issues identified with Eloxatin. However, the possibility for hypersensitivity reactions is raised due to the defects potentially associated with the GMP issues.

Description NDC Lots
(1) Eloxatin (OXALiplatin injection) 50mg/10ml vials 00024-0590-10 BL18B, CB13B, CD65B, CE39B
(2) Eloxatin (OXALiplatin injection) 100mg/20ml vials 00024-0591-20 AD22, AE24, AF55, AD21, AE26, AF03, AF04, AF21, BL19B, BH07, BH08,CB11B, CB102B, CC109B
 

We ask your cooperation in taking the following action:

  • Please examine your inventory, and if you have the recalled product in question immediately cease distribution / use.
  • If you have purchased the product from SSC, fill out the enclosed Return Response Form and send with recall product.
  • Mark the returned product purchased from SSC “Recall Materials Enclosed,” and return to:
    ATTN: LESLIE RIDGEWAY
    HHS Supply Service Center,
    Building 14,
    Perry Point, MD 21902
  • Open containers are not accepted for credit.

Return the affected product before March 13, 2012 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product. Please note customers must reorder the Eloxatin (OXALiplatin injection).

Contact

If you have any questions about this recall, please contact David Wernek, Quality Assurance Specialist at 1-800-642-0263. We apologize for any inconvenience and appreciate your prompt attention to this recall.

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