Recalls / Class II
Class IID-0601-2018
Product
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
- Brand name
- Valganciclovir
- Generic name
- Valganciclovir
- Active ingredient
- Valganciclovir Hydrochloride
- Route
- Oral
- NDC
- 31722-832
- FDA application
- ANDA205166
- Affected lot / code info
- Lot #s VGC17040 & VGC17041, EXP 07/2019
Why it was 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).
Recalling firm
- Firm
- Hetero Labs Limited Unit V
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Unit V (SEZ Unit I in APIIC SEZ), Surv. No. 439-441, 458, Polepally Vill., Jadcherla Mandal, Mahaboob Nagar, N/A, India
Distribution
- Quantity
- 1764 60-count bottles
- Distribution pattern
- NJ and then distributed Nationwide in the USA
Timeline
- Recall initiated
- 2018-02-13
- FDA classified
- 2018-03-16
- Posted by FDA
- 2018-03-21
- Terminated
- 2021-02-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0601-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.