Drug product
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
D-1249-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,729 Bottles
- Official record key
drug-enforcement:D-1249-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: Lot #: LM11172, Expiry: 6/30/2015; Lot #: LN10487, Expiry: 1/31/2016; Lot #: LN10488, Expiry: 1/31/2016; Lot #: LN10489, Expiry: 2/29/2016; Lot #: LN10578, Expiry: 2/29/2016; Lot #: LN10581, Expiry: 2/29/2016; Lot #: LN10582, Expiry: 2/29/2016; Lot #: LN11068, Expiry: 4/30/2016; Lot #: LN11073, Expiry: 4/30/2016; Lot #: LN11125, Expiry: 5/31/2016; Lot #: LN11362, Expiry: 8/31/2016; Lot #: LN11379, Expiry: 8/31/2016; Lot #: LN11380, Expiry: 8/31/2016.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations