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KVK Tech, Inc. FDA Recalls
5 recalls on file across drugs, 2 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 1894Class IIMay 9, 2025cGMP deviations |
| Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, MaClass IIMay 9, 2025cGMP deviations |
| Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10Class ISep 20, 2023Presence of Foreign Tablets/Capsules: There is a potential p |
| Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 1Class IJul 2, 2021Temperature abuse: the firm received customer complaints of |
| Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-TClass IIIApr 27, 2021Failed Impurities/Degradation Specifications |