Class III
Terminated
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
- Company
- Kvk Tech, Inc.
- Recall Initiated
- December 18, 2020
- Posted
- January 20, 2021
- Recall Number
- D-0224-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 528 bottles
- Firm Location
- Newtown, PA, United States
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
Distribution
Nationwide
Lot / Code Info
Batch# 15892A, Exp, 2021-FEB
More recalls by Kvk Tech, Inc.
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc...
May 28, 2025 · Class II
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940,...
Oct 25, 2023 · Class I
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newto...
Sep 1, 2021 · Class I
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026