Why it was recalled
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Product description
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
Lot numbers, UPCs & expiration codes
Lot BP18181301, Exp. Date 02/29/2016
Where it was sold
Indiana
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1110-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 22, 2015
- FDA report date
- Jun 3, 2015
- Quantity
- 50 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blenheim Pharmacal, Inc.
Original FDA data
Every field from FDA enforcement report D-1110-2015, exactly as published.
Show all FDA fields
- City
- North Blenheim
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 71331
- Address
- 119 Creamery Road
- Code information
- Lot BP18181301, Exp. Date 02/29/2016
- Postal code
- 12131
- Report date
- Jun 3, 2015
- Product type
- Drugs
- Recall number
- D-1110-2015
- Classification
- Class II
- Recalling firm
- Blenheim Pharmacal, Inc.
- Product quantity
- 50 bottles
- Termination date
- Jan 15, 2016
- Reason for recall
- cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
- Distribution pattern
- Indiana
- Recall initiation date
- May 22, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 28, 2015