Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30

FDA recall notice · announced February 21, 2018 · Hetero Labs Limited Unit V

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30

Reason for recall

Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot # FMC17039, Exp 07/2019.
Quantity: 8,436 bottles
Status: Terminated
Products in this recall event:
- Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Naga (D-0415-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.