Benzhydrocodone and Acetaminophen Tablets recall: Impurity Out of Spec
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC…
Why was Benzhydrocodone and Acetaminophen Tablets 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch# 15892A, Exp, 2021-FEB
- Product
- Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC…
- Recalling firm
- KVK-Tech, Inc.
- Quantity
- 528 bottles
- Distribution
- Nationwide
- Recall date
- January 20, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)