Recalls / Class II
Class IID-1275-2015
Product
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Affected lot / code info
- A) Lot #: LM10843, Expiry: 5/31/2015; Lot #: LM11331, Expiry: 7/31/2015; Lot #: LM11332, Expiry: 7/31/2015; Lot #: LM11376, Expiry: 7/31/2015; Lot #: LM11583, Expiry: 8/31/2015; Lot #: LM11987, Expiry: 11/30/2015; Lot #: LN10065, Expiry: 12/31/2015; Lot #: LN10066, Expiry: 12/31/2015; Lot #: LN10334, Expiry: 1/31/2016; Lot #: LN10335, Expiry: 1/31/2016; Lot #: LN10443, Expiry: 1/31/2016; Lot #: LN10879, Expiry: 4/30/2016; Lot #: LN10971, Expiry: 4/30/2016; Lot #: LN11178, Expiry: 6/30/2016; Lot #: LN11184, Expiry: 6/30/2016; Lot #: LN11348, Expiry: 7/31/2016. B) Lot #: LM10683, Expiry: 4/30/2015; Lot #: LM10842, Expiry: 5/31/2015; Lot #: LM11377, Expiry: 7/31/2015; Lot #: LM11584, Expiry: 8/31/2015; Lot #: LM11985, Expiry: 11/30/2015; Lot #: LM11988, Expiry: 11/30/2015; Lot #: LN10064, Expiry: 12/31/2015; Lot #: LN10336, Expiry: 1/31/2016; Lot #: LN10446, Expiry: 1/31/2016; Lot #: LN10880, Expiry: 4/30/2016; Lot #: LN10883, Expiry: 4/30/2016; Lot #: LN10972, Expiry: 4/30/2016; Lot #: LN11177, Expiry: 6/30/2016; Lot #: LN11256, Expiry: 7/31/2016.
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271
Distribution
- Quantity
- A) 162,743 Bottles and B) 14,205 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2015-04-22
- FDA classified
- 2015-07-17
- Posted by FDA
- 2015-07-29
- Terminated
- 2018-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1275-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.