Home / Recalls / Hetero Labs, Ltd. - Unit III / D-1019-2018

D-1019-2018 Class II Terminated

Recalled by Hetero Labs, Ltd. - Unit III — Hyderabad, N/A

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

Other recalls by Hetero Labs, Ltd. - Unit III

  • D-1211-2018 Class III — Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Ca (September 12, 2018)
  • D-0594-2018 Class II — Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for C (January 10, 2018)
  • D-0223-2018 Class III — Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: C (December 22, 2017)
  • D-0099-2018 Class II — Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bot (October 12, 2017)