Why it was recalled
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Product description
Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
Lot numbers, UPCs & expiration codes
Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15, K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16.
Where it was sold
Nationwide
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-0560-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 29, 2015
- FDA report date
- Jan 13, 2016
- Quantity
- 45,022 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0560-2016, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 72956
- Address
- 727 N Ann Arbor Ave
- Code information
- Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15, K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16.
- Postal code
- 73127-5822
- Report date
- Jan 13, 2016
- Product type
- Drugs
- Recall number
- D-0560-2016
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 45,022 bottles
- Termination date
- Dec 23, 2016
- Reason for recall
- cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 29, 2015
- Initial firm notification
- Center classification date
- Jan 5, 2016