Amerisource Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure
Amerisource Health Services is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because stability samples 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 indicates a remote possibility of adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute safety hazard.
Plain-English summary
Amerisource Health Services is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg. The affected products are available in 90-count and 500-count bottles and were distributed nationwide and in Puerto Rico.
The recall was initiated after the firm was notified that 6-month stability samples failed to meet dissolution specifications. This means the tablets may not release the medication in the body as intended.
Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance. The specific lot numbers and expiration dates are listed in the structured product information.
The recalled product
- Product
- Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
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 (8)
- Lot #: a) M601509
- Exp 3/31/2018
- M606506
- Exp 4/30/2018
- b) M601510
- M604444
- M606515
- Exp 4/30/2018.
Distribution
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