American Health Packaging Recalls Raloxifene Hydrochloride Tablets for Dissolution Failure
American Health Packaging is recalling 973 cartons of Raloxifene Hydrochloride 60 mg tablets due to low dissolution results found during stability testing.
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 that may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a dangerous substance, and no illnesses or injuries are reported.
Plain-English summary
American Health Packaging is voluntarily recalling 973 cartons of Raloxifene Hydrochloride Tablets, USP, 60 mg. The affected product is packaged in 30-tablet blister cards and is distributed nationwide within the United States. The specific lot number is 180276A, with an expiration date of 02/29/2020.
The recall was initiated because low out-of-specification results were obtained during stability testing for dissolution. Dissolution testing ensures that the active ingredient in the tablet is released at the appropriate rate when taken. If the dissolution is too low, the medication may not work as intended.
Consumers and healthcare providers who have this specific lot of Raloxifene Hydrochloride should stop using it and contact their pharmacist or physician for guidance. The product is prescription-only, so patients should consult their healthcare provider before discontinuing or replacing the medication.
The recalled product
- Product
- RALOXIFENE HYDROCHLORIDE (RALOXIFENE)
- Brand
- RALOXIFENE HYDROCHLORIDE
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 973
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 #:180276A
- Exp date 02/29/2020
Distribution
Distributed nationwide across the United States.
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