Home / Recalls / KVK-Tech, Inc. / D-0532-2020

D-0532-2020 Class II Terminated

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

Recall Details

Product Type: Drugs
Report Date: November 20, 2019
Initiation Date: November 1, 2019
Termination Date: April 16, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1534 bottles

Product Description

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

Reason for Recall

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN

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-0224-2021 Class III — Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx O (December 18, 2020)
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)