D-1019-2018 Class II Terminated
FDA drug recall D-1019-2018 was initiated by Hetero Labs, Ltd. - Unit III on July 18, 2018 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules. The recall status is terminated (terminated July 15, 2021). Affected quantity: 18,288 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 8, 2018
- Initiation Date
- July 18, 2018
- Termination Date
- July 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,288 bottles
Product Description
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Reason for Recall
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: E180315, Exp 12/19