Amerisource Recalls bupropion Hydrochloride Tablets for Dissolution Failure
Amerisource Health Services is recalling 2,626 bottles of bupropion hydrochloride extended-release tablets due to failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 the rubric associates with scores of 1 or 2. A score of 2 is assigned as it involves a pharmaceutical product with a quality specification failure, rather than a purely cosmetic or documentation issue.
Plain-English summary
Amerisource Health Services is recalling 2,626 bottles of buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg. The product is identified by Lot # MS1509 and an expiration date of 12/17. The recall was initiated because the tablets failed dissolution specifications, a result identified during 3-month stability testing.
The affected product was distributed nationwide and in Puerto Rico. The tablets are manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, for BluePoint Laboratories. The NDC number for the product is 68001-264-03.
Consumers with this specific lot of medication should contact their healthcare provider or pharmacist for guidance on replacing the medication. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,626
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 #: MS1509
- Exp 12/17
Distribution
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