FDAFDA · Food and drugs·Recall number D-0224-2021
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
Published January 20, 2021 · Recall initiated: December 18, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KVK-Tech, Inc.
- Distributor
- Nationwide
- Lot
- Batch# 15892A, Exp, 2021-FEB
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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