CLASS II Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report
Clarithromycin tablets, USP 500mg recalled by American Health Packaging
American Health Packaging is recalling Clarithromycin tablets, USP 500mg, distributed nationwide in the US. The recall was initiated on 1 Jun 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-1224-2015
- FDA event ID
- 71553
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2015
- FDA classified
- 8 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 1 Jun 2015 | Recall initiated by company | |
| 8 Jul 2015 | Classified by FDA | +37 days |
| 15 Jul 2015 | Published in enforcement report | +7 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: Firm did not adequately investigate customer complaints.
Product as listed by the FDA
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
Is Clarithromycin tablets, USP 500mg recalled?
Yes. American Health Packaging recalled Clarithromycin tablets, USP 500mg on 1 Jun 2015. The recall is Class II and its status is Terminated. Recall number D-1224-2015.
Why was it recalled?
CGMP Deviations: Firm did not adequately investigate customer complaints.
Which lots are affected?
Lot#: 132323, Exp 07/31/2015; Lot#: 132960, Exp 09/30/2015; Lot#: 133707A, Exp 10/31/2015; Lot#: 133707B, Exp 11/30/2015.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Health Packaging
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| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
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| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Clarithromycin recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clarithromycin Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clarithromycin Tablets, USP, 500 mg recalled by Blenheim Pharmacal | Blenheim Pharmacal | Manufacturing (CGMP) Deviations | IN |