Home / Recalls / Hetero Labs, Ltd. - Unit III / D-1211-2018

D-1211-2018 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
October 3, 2018
Initiation Date
September 12, 2018
Termination Date
November 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,424 bottles

Product Description

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Reason for Recall

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 Pattern

Indiana and Louisiana

Code Information

Lot #: E181370, Exp. 5/2020

Other recalls by Hetero Labs, Ltd. - Unit III

  • D-1019-2018 Class II — Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: (July 18, 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)