Mylan Recalls Bupropion HCL Extended-Release Tablets Due to Impurities
Mylan Pharmaceuticals is voluntarily recalling specific bottles of bupropion HCL extended-release tablets due to out-of-specification impurities found during routine stability testing.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is conducting a voluntary recall of bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottles. The recall is limited to Lot # 3077281 with an expiration date of 06-2018. The company identified out-of-specification compound results during routine stability testing, which triggered the recall action.
The affected product is a prescription-only medication distributed nationwide in the USA. A total of 1,414 bottles of the 500-count size are subject to this recall. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the recalled medication.
The recalled product
- Product
- bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
- Manufacturer
- Mylan Pharmaceuticals Inc.
- 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 (2)
- Lot # 3077281
- EXP 06-2018
Distribution
Distributed nationwide across the United States.
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