KVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles
KVK-Tech is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution because black particles were found during inspection.
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 II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The presence of foreign particles (black particles) is a quality defect that poses a potential risk, but no specific injuries or illnesses are reported in the source text, aligning with a Moderate severity rating for a drug recall involving physical contamination without reported harm.
Plain-English summary
KVK-Tech, Inc. is recalling 1,534 bottles of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (5 mg/1.5 mg per 5 mL, 473 mL bottles). The affected product is a prescription-only medication manufactured by KVK-Tech, Inc. in Newtown, PA, with NDC 10702-150-16.
The recall was initiated because black particles were discovered in the product during retain sample inspection. The affected lots are 14375A (expiration date December 2019) and 14398A (expiration date January 2020). The product was distributed nationwide within the United States.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for disposal. Patients should not use the recalled product and should contact their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION)
- Brand
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Manufacturer
- KVK-Tech, Inc.
- Hazard
- Affected units
- 1,534
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 (4)
- Lot #: 14375A
- Exp. date 2019-DEC
- 14398A
- Exp. date 2020-JAN
Distribution
Distributed nationwide across the United States.
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