D-0223-2018 Class III Terminated
FDA drug recall D-0223-2018 was initiated by Hetero Labs, Ltd. - Unit III on December 22, 2017 and is designated Class III. Reason for recall: Presence of foreign substance: metallic razor blade was found in one bottle. The recall status is terminated (terminated March 23, 2018). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2018
- Initiation Date
- December 22, 2017
- Termination Date
- March 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Reason for Recall
Presence of foreign substance: metallic razor blade was found in one bottle.
Distribution Pattern
U.S.A. nationwide
Code Information
Lot #: E171280, Exp 06/19