Home / Recalls / KVK-Tech, Inc. / D-0224-2021

D-0224-2021 Class III Terminated

Recalled by KVK-Tech, Inc. — Newtown, PA

Recall Details

Product Type: Drugs
Report Date: January 20, 2021
Initiation Date: December 18, 2020
Termination Date: March 19, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 528 bottles

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

Distribution Pattern

Nationwide

Code Information

Batch# 15892A, Exp, 2021-FEB

Other recalls by KVK-Tech, Inc.

D-0049-2024 Class I — Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., (September 20, 2023)
D-0772-2021 Class I — Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: K (July 2, 2021)
D-0386-2021 Class III — Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, (April 27, 2021)
D-0532-2020 Class II — Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg p (November 1, 2019)
D-0142-2020 Class III — Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Fr (October 4, 2019)
D-0340-2019 Class II — Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK- (December 11, 2018)
D-1083-2017 Class III — Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702 (August 3, 2017)
D-1057-2016 Class III — Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KV (May 5, 2016)
D-1371-2015 Class III — Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (July 14, 2015)
D-1032-2014 Class II — HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mf (December 11, 2013)