KVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity
KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets because the N-Oxide impurity exceeded specifications during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets, 6.12mg/325mg, 100 count, NDC 10702-344-01. The affected product is identified by Batch# 15892A and an expiration date of February 2021. The recall is being conducted because the product failed impurities/degradation specifications, specifically showing out-of-specification results for the N-Oxide impurity during 12-month long-term stability testing.
The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The product was distributed nationwide. No specific illnesses or injuries have been reported in the source text.
Consumers who have this specific batch of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- 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
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch# 15892A
- Exp
- 2021-FEB
Distribution
Distributed nationwide across the United States.
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