Newtown, PA, United States
KVK-Tech, Inc. recalls
7 recalls recorded since 2018, most recently on 20 September 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)0
Terminated or completed7
Class I (FDA)2
Terminated Class I Drugs
- Recall started
- 20 September 2023
- Terminated
- 29 July 2025
- Reason
- Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
- Distribution
- Nationwide in the USA and PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0049-2024
- Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Terminated Class I Drugs
- Recall started
- 2 July 2021
- Terminated
- 23 May 2022
- Reason
- Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
- Distribution
- Product was distributed to one distributor who may have further distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0772-2021
- Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
Terminated Class III Drugs
- Recall started
- 27 April 2021
- Terminated
- 5 October 2022
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0386-2021
- Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03
Terminated Class III Drugs
- Recall started
- 18 December 2020
- Terminated
- 19 March 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0224-2021
- 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
Terminated Class II Drugs
- Recall started
- 1 November 2019
- Terminated
- 16 April 2020
- Reason
- Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0532-2020
- 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
Terminated Class III Drugs
- Recall started
- 4 October 2019
- Terminated
- 20 April 2020
- Reason
- Presence of Foreign Substance; Fiber particles.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0142-2020
- Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
Terminated Class II Drugs
- Recall started
- 11 December 2018
- Terminated
- 1 May 2019
- Reason
- Labeling: Wrong bar code
- Distribution
- Product was distributed by 10 major distributors throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0340-2019
- Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.