D-0897-2017 Class III Terminated

Recalled by Hetero USA Inc — Piscataway, NJ

Recall Details

Product Type
Drugs
Report Date
June 14, 2017
Initiation Date
April 27, 2017
Termination Date
December 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,692 bottles

Product Description

Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01

Reason for Recall

Presence of Foreign Substance: human hair melded into tablet.

Distribution Pattern

Nationwide

Code Information

Lot # ACY16075 Exp. 09/2018