Azithromycin 500 mg tablets — Class II drug recall D-0561-2016
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2016-01-13, distributed nationwide. cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adeq
| Recall number | D-0561-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2016-01-05 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 17,533 bottles |
| Reason classes | cgmp |
| NDC | 55289-0274-02, 55289-0274-03, 55289-0274-07, 55289-0274-79 |
| Lot numbers | 01/15, 02/15, 04/15, 05/15, 06/15, 07/15, 08/15, 09/15, 10/14, 10/15, 11/15, 12/14, 12/15, A13G14, A13H49, A14C27, A14D09, A14F11, B13G53, D13A66, E13E35, F13A58, F13D85, F13F17, F13F27, G13D37, G13E57, H13A65, H13A74, H13C13, H13G01, I13C02, I13G98, J12C03, J12D19, J13C53, J13G90, K13A65, K13B73, K13C98 and 6 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0561-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.