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
Reported: January 20, 2021 Initiated: December 18, 2020 #D-0224-2021
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Details
- Recalling Firm
- KVK-Tech, Inc.
- Units Affected
- 528 bottles
- Distribution
- Nationwide
- Location
- Newtown, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by KVK-Tech, Inc.. Units affected: 528 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 20, 2021. Severity: Low. Recall number: D-0224-2021.
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