Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Reported: March 29, 2017 Initiated: February 15, 2017 #D-0610-2017
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.
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 116 cartons
- Distribution
- Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13. Recalled by AVKARE Inc.. Units affected: 116 cartons.
Why was this product recalled? ▼
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2017. Severity: Moderate. Recall number: D-0610-2017.
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