Home / Recalls / Hetero Labs, Ltd. - Unit III / D-0223-2018

D-0223-2018 Class III Terminated

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

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-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-0099-2018 Class II — Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bot (October 12, 2017)