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 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
Lot numbers, UPCs & expiration codes
Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15, L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.
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-0561-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 29, 2015
- FDA report date
- Jan 13, 2016
- Quantity
- 17,533 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0561-2016, 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: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15, L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.
- Postal code
- 73127-5822
- Report date
- Jan 13, 2016
- Product type
- Drugs
- Recall number
- D-0561-2016
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 17,533 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 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 29, 2015
- Initial firm notification
- Center classification date
- Jan 5, 2016