Recalls / Class II
Class IID-0415-2018
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
- Brand name
- Famciclovir
- Generic name
- Famciclovir
- Active ingredient
- Famciclovir
- Route
- Oral
- NDCs
- 31722-706, 31722-707, 31722-708
- FDA application
- ANDA202438
- Affected lot / code info
- Lot # FMC17039, Exp 07/2019.
Why it was recalled
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.
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
- 8,436 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2017-12-22
- FDA classified
- 2018-02-15
- Posted by FDA
- 2018-02-21
- Terminated
- 2020-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0415-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.