Reported Jan 20, 2021 · Terminated
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc.,…
KVK-Tech, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KVK-Tech, Inc. · 110 Terry Dr · Newtown, PA · 18940-3427
Is this the product you have?
- Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only
- Manufactured forKVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
- Lot codes and dates
Batch# 15892AExp2021-FEB
- Amount recalled
- 528 bottles
Where it was sold
- Nationwide
Why it was 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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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