Drug 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
D-0897-2017
Product summary
- Firm
- Hetero USA Inc
- Event
- Event 77122
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,692 bottles
- Official record key
drug-enforcement:D-0897-2017
Official wording
Reason: Presence of Foreign Substance: human hair melded into tablet.
Code information: Lot # ACY16075 Exp. 09/2018
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance