Hyderabad, N/A, India
Hetero Labs, Ltd. - Unit III recalls
4 recalls recorded since 2018, most recently on 12 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 12 September 2018
- Terminated
- 29 November 2018
- Reason
- Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
- Distribution
- Indiana and Louisiana
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1211-2018
- Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Terminated Class II Drugs
- Recall started
- 18 July 2018
- Terminated
- 15 July 2021
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1019-2018
- 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-
Terminated Class II Drugs
- Recall started
- 10 January 2018
- Terminated
- 21 September 2020
- Reason
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Distribution
- NJ Only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0594-2018
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India,
Terminated Class III Drugs
- Recall started
- 22 December 2017
- Terminated
- 23 March 2018
- Reason
- Presence of foreign substance: metallic razor blade was found in one bottle.
- Distribution
- U.S.A. nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0223-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.