KVK-Tech Recalls Hydrocodone and Homatropine Tablets for Impurity Failures
KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets due to failed impurities and degradation specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets, USP, 5 mg/1.5 mg, 30-count bottles. The recall is due to the product failing impurities and degradation specifications.
The affected product is identified by Lot 15684A with an expiration date of 7/2021. The NDC number is 10702-055-03. The product was distributed nationwide in the USA.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
- Brand
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,096
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 (2)
- Lot: 15684A
- Exp 7/2021
Distribution
Distributed nationwide across the United States.
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