American Health Packaging Recalls Doxycycline Hyclate Tablets for Dissolution Failure
American Health Packaging is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The affected lot was distributed nationwide.
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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling hazard.
Plain-English summary
American Health Packaging is recalling Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only. The recall involves 6,579 cartons of the medication, identified by Lot 172569 with an expiration date of 7/31/2019. The product is distributed by American Health Packaging, Columbus, Ohio, and carries the NDC Carton 62584-693-21 and NDC Unit Dose 62584-693-11.
The recall was initiated because the product failed to meet dissolution specifications, resulting in an out-of-specification result for the dissolution test. This defect may affect the drug's performance and efficacy.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE HYCLATE
- Manufacturer
- American Health Packaging
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 6,579
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 172569
- Exp 7/31/2019
Distribution
Distributed nationwide across the United States.
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