Class II · Moderate risk
Clarithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Clarithromycin Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
Affected NDCs
10544-0522-20
64679-0904-02
Compare with the code on your package — it is the most precise check available.
Drug: Clarithromycin
- Recalling firm
- Blenheim Pharmacal, Inc.
- NDC code
- 10544-522-20
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1110-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clarithromycin recalls
See all
Class II · Moderate risk
Clarithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Clarithromycin active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
triple therapy
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
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All 2015 recalls
Class II · Moderate risk
Captopril Tablets
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
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All cgmp deviation recalls
Class II · Moderate risk
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