LinkedIn Logo
msc-bulletin-banner

Amlodipine Besylate Drug Recall

October 9, 2013

Mylan Pharmaceuticals, Inc. is conducting a voluntary recall of the below referenced pharmaceutical lots due to GMP compliance issues identified at Smruthi’s manufacturing facility, a third party raw material manufacturer. This recall is based on close collaboration with FDA.

Description

Lot# and Expiration Date

NDC

Amlodipine Besylate/ Benazepril HCL Capsules 5mg/10mg 500’s

2003158 12/2013; 2003159 12/2013; 3043492 10/2014

00378689605

Amlodipine Besylate/ Benazepril HCL Capsules 10mg/20mg 500’s

2003176 12/2013; 2003177 12/2013; 3043496 10/2014

00378689805

Amlodipine Besylate/ Benazepril Capsules 5mg/20mg 500’s

2003168 12/2013; 2003169 12/2013; 3043493 10/2014

00378689705

Amlodipine Besylate/ Benazepril HCL Capsules 10mg/20mg 100’s

2003177 12/2013; 2003178 12/2013; 2003179 12/2013; 2003180 12/2013; 3043496 10/2014

00378689801

Amlodipine Besylate/ Benazepril HCL Capsules 10mg/40mg 100’s

2003188 12/2013; 2003189 12/2013; 2003190 12/2013; 2003191 12/2013; 3043498 10/2014

00378690001

Amlodipine Besylate/ Benazepril HCL Capsules 2.5mg/10mg 100’s

2003155 12/2013; 2003156 12/2013; 2003157 12/2013; 3043491 10/2014

00378689501

Amlodipine Besylate/ Benazepril HCL Capsules 5mg/10mg 100’s

2003159 12/2013; 2003160 12/2013; 2003161 12/2013; 3043492 10/2014

00378689601

Amlodipine Besylate/ Benazepril HCL Capsules 5mg/20mg 100’s

2003169 12/2013; 2003171 12/2013; 2003172 12/2013; 2003173 12/2013; 3002170 12/2013; 3043493 10/2014

00378689701

Amlodipine Besylate/ Benazepril HCL Capsules 5mg/40mg 100’s

2003184 12/2013; 2003185 12/2013; 2003186 12/2013; 3013495 10/2014

00378689901

Amlodipine Besylate/ HCL Tablets 10mg 90’s

3038984 05/2014; 3038985 05/2014; 3038986 05/2014; 3041484 08/2014; 3041485 08/2014

00378521077

Amlodipine Besylate/ HCL Tablets 10mg 500’s

3036828 02/2014; 3036829 02/2014; 3036830 02/2014; 3036831 02/2014; 3036832 02/2014; 3038987 05/2014; 3038988 05/2014; 3038989 05/2014; 3038990 05/2014; 3041480 08/2014; 3041481 08/2014; 3041482 08/2014; 3041483 08/2014; 3044522 12/2014; 3044525 12/2014

00378521005

Amlodipine Besylate HCL Tablets 2.5mg 90’s

3037907 04/2014; 3040106 07/2014

00378520877

Amlodipine Besylate HCL Tablets 5mg 90’s

3036490 02/2014; 3036491 02/2014; 3036492 02/2014; 3039874 06/2014

00378520977

Amlodipine Besylate HCL Tablets 5mg 500’s

3036493 02/2014; 3036494 02/2014; 3039872 06/2014; 3039873 06/2014; 3041476 08/2014; 3041477 08/2014; 3044555 12/2014; 3044683 12/2014

00378520905

Amlodipine Besylate HCL Tablets 2.5mg 500’s

3037907 04/2014; 3040106 07/2014; 3044357 12/2014

00378520805

Lamotrigine Tablets 200mg 60’s

2003194 01/2014; 2003195 01/2014

00378425491

Lamotrigine Tablets 200mg 500’s

2003193 01/2014

00378425405


An assessment of our inventory shows that the Center stocks this product (Amlodipine Besylate Tablets, USP 5mg 90’s) under NSN 6505-00-000-3292. 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.
  • Fill out enclosed Return Response Form and send with recall.
  • Mark the returned product purchased from SSC “Recall Materials Enclosed,” and return to:
    Attn: Heather Ward
    HHS Supply Service Center,
    Building 14,
    Perry Point, MD 21902
  • Please return the affected product before November 30th, 2013 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product.

Contact

If you have any questions about this recall, please contact Heather Ward, Quality Assurance Specialist at 1-800-642-2244 Ext: 1397. We apologize for any inconvenience and appreciate your prompt attention to this recall.

 

TO THE TOP


Ciprofloxacin Tablets Recall

October 04, 2013

Mylan Pharmaceuticals, Inc. is conducting a voluntary recall of Ciprofloxacin Tablets manufactured utilizing Active Pharmaceutical Ingredient (API) supplied by Smruthi Organics Ltd., a third party raw material manufacturer. Based on close collaboration with FDA, these products are being recalled due to GMP compliance issues identified at Smruthi’s manufacturing facility. Affected lots were distributed between June 30th, 2011 and December 25th, 2012.

NDC

Product Description

Size

0378-7097-01

Ciprofloxacin Tablets, USP 250mg

Bottles of 100’s

0378-7098-01

Ciprofloxacin Tablets, USP 500mg

Bottles of 100’s

 

Recalled Lots Include:

Ciprofloxacin Tablets, USP 250mg Bottles of 100: Lot No. 3032075, 3032076

Ciprofloxacin Tablets, USP 500mg, Bottles of 100:
Lot No. 2002732, 2002733, 2002734, 2002735, 2002736, 2002737, 2002738, 2002739, 2002740, 2002741, 2002742, 2002743, 2002744, 2002745, 3030000, 3030001, 3030002, 3030003, 3030004, 3030005, 3030006, 3030016, 3030017, 3030018, 3030216, 3030217, 3030218, 3030216, 3030217, 3030218, 3030219, 3030220, 3030221, 3030222, 3030223, 3030224, 3030225, 3030226, 3030227, 3030228, 3030229, 3030238, 3030351, 3030352, 3030354, 3030355, 3030356, 3030357, 3030358, 3031790, 3031792, 3031793, 3031794, 3031795, 3031796, 3031797, 3031798, 3032035, 3032036, 3032037, 3032038, 3032039, 3032040, 3032041, 3032042, 3032043, 3032044, 3032045, 3032046

An assessment of our inventory shows that the Center stocks this product (Ciprofloxacin Tablets, USP 500mg 100’s) under NSN 6505-00-000-6899. We ask for your cooperation in taking the following action:

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 Supply Chain Management Services, fill out the “Return Response Form” and send with recall product.
  • Mark the returned product purchase from SCMS “Recall Materials Enclosed” and return to:
    ATTN: Heather Ward
    HHS Supply Chain Management Services
    Building 14
    Perry Point, MD 21902
  • Used product is not accepted for credit.

Please return the affected product before November 30th, 2013 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product.

Contact

If you have any questions about this recall, please contact Heather Ward, Quality Assurance Specialist at 1-800-642-2244 Ext: 1397. We apologize for any inconvenience and appreciate your prompt attention to this recall.

TO THE TOP

The lots affected include: 67331A, 69099B, 69100A, 69099B, 69099A, 69098B, 69099A, and 69098A.


Belladonna Alkaloids with Phenobarbital Tablets Recall

June 3, 2013

The West-Ward Corporation is conducting a voluntary recall of the below item/lots. This voluntary recall is due to a spot observed on a tablet. An analysis and health hazard assessment was conducted on the affected tablet identifying the make-up of the spot and concluding that the risk to safety or efficacy of the product is unlikely due to trace quantity. Please see the attachment for return processing.

An assessment of our inventory shows that the Center stocks this product. 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 Supply Chain Management Services, fill out the “Return Response Form” and send with recall product.
  • Mark the returned product purchase from SCMS “Recall Materials Enclosed” and return to:
    ATTN: John Diesel
    HHS Supply Chain Management Services
    Building 14
    Perry Point, MD 21902
  • Used product is not accepted for credit.

Please return the affected product before June 30th, 2013 to expedite processing of your return goods credit. Accounts will be credited upon receipt of the recalled product.

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.

TO THE TOP


2013-2014 Influenza Virus Vaccine Ordering Procedures

May 28, 2013

The Supply Service Center has commenced taking orders for the 2013-2014 Influenza Virus Vaccine. All ordering activities are advised to consolidate their requirements for the 2013-2014 flu season and place their orders as soon as possible so we can better plan to meet customer needs.

INFLUENZA VIRUS QUADRIVALENT VACCINE 2013-2014

NSN

Product Description

U/I

Price

6505-00-00-8034

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

Syringes

$119.23

6505-00-000-8035

Multiple Dose 5 ml Vial (10 doses) Fluzone®

Vial

$71.63

 

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 composition for the trivalent U.S. 2013-2014 influenza vaccine season contains the following:

  • A/California/7/2009 (H1N1)-like virus
  • (H3N2) virus antigenically like the cell-propagated prototype virus
  • A/Victoria/361/2011
  • B/Massachusetts/2/2012-like virus

We request that 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 2013-2014 Influenza Virus Vaccine SSC contract is Fluzone® from Sanofi. Please note that Fluzone® multi-dose vial is for ages 6 months and older, but contains a small amount of preservative. The prefilled syringes are for 36 months and older and are preservative free. Please notify us if you have patients younger than 3 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.

 

TO THE TOP


Repackaged Doxycycline 100mg Capsules

May 28, 2013

Doxycycline is an antimicrobial agent from the tetracycline family. It’s virtually completely absorbed after oral administration and is bound to plasma proteins, which makes it one of the drugs of choice for an anthrax exposure and malaria, amongst other indications. Due to raw material availability the product is on constant backorder and those able to retrieve the raw material have done so at a very high cost.

SSC has acquired material at the original low cost, before the high spike in price, but the unit of measure is not readily sold. In order to meet our customers’ demands we have decided to repackage these into unit of measures (UOM) that are frequently used and requested by our customers. We have maintained the low price, but these supplies are limited. Once these are depleted we may not be able to repackage these at this price.

ParaGard T 380A – Intrauterine Copper Contraceptive

NSN

Description

Repackaging Price

6505-00-000-8037

DOXYCYCLINE HYCLATE CAP,100MG,20S,REPK

$9.35

6505-00-369-7296

DOXYCYCLINE HYCLATE CAP,100MG,50S,REPK

$22.25

6505-00-000-8038

DOXYCYCLINE HYCLATE CAP,100MG,100S,REPK

$43.75

 

SSC is constantly working to procure the products our valued customers require to fulfill their healthcare needs. Thanks to our business relationship with our vendors, we often can purchase product that may not be available in the general marketplace.

Contact

You can place your requests with Customer Service at 1-800-642-0263. If you have any questions or concerns I can be contacted at Annette.Quinones@psc.hhs.gov or 410-642-1386.

As always, thank you for letting us serve you in providing you with your medical supply needs.

TO THE TOP


Vaccine Availability

March 27, 2013

SSC is constantly working to procure the products our valued customers require to fulfill their healthcare needs. Thanks to our business relationship with our vendors, we often can purchase product that may not be available in the general marketplace.

Poliovirus Vaccine Inactivated (IPOL®)

Sanofi Pasteur has been on backorder with the prefilled Syringes since 2010. At this time, they have not released a date as to when this product may be available. The 5ml 10 dose multi-dose vial is available under 6505-00-000-3841. Once the multidose vial is opened, it is good until its expiration date as long as it is handled and stored properly.

Polio

Typhoid Vi Polysaccharide Vaccine (TYPHIM®)

Currently, Sanofi Pasteur does not have any available inventory. The due date for the Typhoid prefilled syringes is July 2013. The 20 dose vial is available under 6505-01-385-6328. Once the multi-dose vial is opened it, is good until its expiration date as long as it is handled and stored properly.

Typhoid

Tetanus Toxoid Reduced Diphtheria and Acellular Pertussis Vaccine Adsorbed

Both Tdap formulations Adacel® (Sanofi) and Boostrix® (GSK) are available in the single dose vials. The 10 pack prefilled syringes are on backorder with GSK, but they are available in a package of 5 prefilled syringes from Sanofi, under 6505-00-000-7993.

TDAP

Rabies Vaccine

Both Imovax® (Sanofi) and Rabavert® (Novartis) are on allocation for post-exposure only. We have a limited amount of stock available of the Rabavert®, under 6505-01-456-8888.

Rabies

Contact

If you have an urgent requirement for a specific vaccine, we ask that you provide a brief justification, and we’ll work with our vendors to fill your critical need. Please contact Annette Quinones at Annette.Quinones@psc.hhs.gov or 410-642-1386 for any questions on vaccine availability.

As always, we appreciate the opportunity to serve your medical supply needs.

TO THE TOP


Alere Cholestech LDX® Multianalyte Control Recall

March 14, 2013

Alere San Diego, Inc. has issued a voluntary recall for the Alere Cholestech LDX® Multianalyte Control, 2 vial set, Catalog Number 888769, Lot numbers, C2572, C2572A, C2593 and C2593A.

The above listed lot numbers were investigated and it was confirmed that these lots of the LDX Multianalyte Controls may yield results which are out of range high when tested with Alere Cholestech LDX HDL test.

Our inventory records have indicated that we stock the Multianalyte Control under NSN 6550-00-000-6569 and you may have received one or more of the aforementioned kits.

We ask your cooperation in taking the following action:

  • Please examine your inventory and discontinue use of these lots and dispose of them in accordance with your local regulations.
  • Please refer to the Alere Customer/ Distributor Verification Form. This must be filled out and faxed back to Alere.

Contact

If you have any questions about this recall, please contact John Diesel, SSC Quality Assurance Specialist, at 1-800-642-0263 Ext: 1128 or Alere San Diego Inc. at 1-877-308-8289. We apologize for any inconvenience caused and thank you in advance for your prompt attention to this urgent request.

TO THE TOP