Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Captopril 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
Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02
Affected NDCs
10544-0175-30
64679-0904-02
Compare with the code on your package — it is the most precise check available.
Drug: Captopril
- Recalling firm
- Blenheim Pharmacal, Inc.
- NDC code
- 10544-175-30
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1109-2015 · 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 Captopril recalls
See all
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
Failed Tablet/Capsule Specifications: out of specification for thickness.
Other recalls by Blenheim Pharmacal, Inc.
All 2015 recalls
Class II · Moderate risk
Clarithromycin 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
Other cgmp deviation recalls from 2015
All cgmp deviation recalls
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