Recalls / Class II
Class IID-0610-2017
Product
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
- Affected lot / code info
- Lot #15152, Exp. 02/2018
Why it was recalled
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 116 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-15
- FDA classified
- 2017-03-22
- Posted by FDA
- 2017-03-29
- Terminated
- 2022-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0610-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.