Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failure
Sun Pharmaceutical Industries is recalling 16,085 bottles of Bupropion Hydrochloride Extended Release Tablets because they 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the violation is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 16,085 bottles of Bupropion Hydrochloride Extended Release Tablets USP (SR) 150 mg. The affected product is identified by Lot JKN3477A with an expiration date of 07/2016. The recall was initiated because the tablets failed to meet dissolution specifications.
The recalled product is distributed nationwide. The medication is a prescription-only oral drug manufactured by Sun Pharmaceutical Ind. Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.
Consumers who have this specific lot of Bupropion Hydrochloride should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 16,085
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 JKN3477A
- exp 07/2016
UPCs (2)
- 0347335738865
- 0347335737868
Distribution
Distributed nationwide across the United States.
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