Sun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure
Sun Pharma Global Fze is recalling 35,235 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed to meet drug release specifications during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, 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
Sun Pharma Global Fze is recalling 35,235 bottles of Bupropion Hydrochloride Extended-Release Tablets USP (SR), 200 mg. The affected product is distributed nationwide and in Puerto Rico. The specific lots involved are JKM4152A, JKM4737A, and JKM5270A, all with an expiration date of 08/2015.
The recall was initiated because the product failed to meet dissolution specifications. During 18-month long-term stability testing, analysis showed that the drug release results at the 4-hour time point did not meet required standards. This indicates that the tablets may not release the medication as intended.
Consumers who have these specific bottles should stop using the product and contact their healthcare provider or pharmacist for guidance. The FDA classifies this as a Class III recall, which is the lowest risk category, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Sun Pharma Global Fze
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 35,235
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 (4)
- Lot #s: JKM4152A
- JKM4737A
- JKM5270A
- Exp 08/2015
UPCs (2)
- 0347335738865
- 0347335737868
Distribution
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