D-0610-2017 Class II Terminated
FDA drug recall D-0610-2017 was initiated by AVKARE Inc. on February 15, 2017 and is designated Class II. Reason for recall: Failed impurities/ degradation specifications: Product was above specification for unknown impurities. The recall status is terminated (terminated June 1, 2022). Affected quantity: 116 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2017
- Initiation Date
- February 15, 2017
- Termination Date
- June 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116 cartons
Product Description
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Reason for Recall
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Distribution Pattern
Nationwide
Code Information
Lot #15152, Exp. 02/2018