Home / Recalls / Hetero Labs, Ltd. - Unit III / D-0099-2018

D-0099-2018 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
December 6, 2017
Initiation Date
October 12, 2017
Termination Date
September 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4050 bottles

Product Description

Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47

Reason for Recall

Presence of foreign substance (screw)

Distribution Pattern

NJ

Code Information

Lot # E170346, Exp 02/19

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-0223-2018 Class III — Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: C (December 22, 2017)