CLASS II Drug recall · Reported 13 Jan 2016 · FDA Enforcement Report
Azithromycin Tablets, USP, 250 mg recalled by PD-Rx Pharmaceuticals
PD-Rx Pharmaceuticals is recalling Azithromycin Tablets, USP, 250 mg, distributed nationwide in the US. The recall was initiated on 29 Apr 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0560-2016
- FDA event ID
- 72956
- Recalling firm
- PD-Rx Pharmaceuticals, Oklahoma City, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2015
- FDA classified
- 5 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 29 Apr 2015 | Recall initiated by company | |
| 5 Jan 2016 | Classified by FDA | +251 days |
| 13 Jan 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Which lots are affected?
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 was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72956| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) recalled | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from PD-Rx Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Nitrosamine Impurity | FL, MS, WI |
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Azithromycin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azithromycin for Injection USP Vial, 500 mg per vial recalledAzithromycin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) recalled | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azithromycin Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azithromycin Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azithromycin Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |