InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures
InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.
What this means for you
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 FDA classifies this as a Class III recall, which is by definition unlikely to cause adverse health consequences. The rubric maps Class III recalls to a score of 1 or 2; a score of 2 is appropriate for a voluntary precautionary recall involving a quality specification failure without reported illness.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets, USP (SR), 100 mg. The affected products are 60-count bottles, prescription-only, manufactured for Cipla USA Inc. and manufactured by InvaGen Pharmaceuticals, Inc.
The recall was initiated because the tablets failed dissolution specifications during stability testing. The affected lots are I1606579 and I1606580 (expiration 05/2018) and I1612114 and I1612115 (expiration 11/2018). The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The FDA classifies this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE (SR)
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- 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# I1606579 and Lot# I1606580 Exp: 05/2018
- Lot# I1612114 and Lot# I1612115 Exp: 11/2018
UPCs (3)
- 0369097879037
- 0369097878030
- 0369097877033
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by InvaGen Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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