Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
Reported: March 21, 2018 Initiated: February 13, 2018 #D-0601-2018
Product Description
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
Reason for Recall
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Details
- Recalling Firm
- Hetero Labs Limited Unit V
- Units Affected
- 1764 60-count bottles
- Distribution
- NJ and then distributed Nationwide in the USA
- Location
- Jadcherla Mandal, Mahaboob Nagar
Frequently Asked Questions
What product was recalled? ▼
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60. Recalled by Hetero Labs Limited Unit V. Units affected: 1764 60-count bottles.
Why was this product recalled? ▼
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 21, 2018. Severity: Moderate. Recall number: D-0601-2018.
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