FDA recall D-0897-2017

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2017-04-27

Report date

2017-06-14

Termination date

2017-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0897-2017