InvaGen Recalls Bupropion Hydrochloride Tablets Due to Impurity Levels
InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride ER tablets because older batches failed impurity specifications.
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 classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling 26,496 bottles of Bupropion Hydrochloride ER Tablets, USP 150 mg. The affected products are packaged in 90-count bottles and were distributed nationwide to 14 major distributors. The recall involves specific lot numbers and expiration dates for products manufactured for Cipla USA Inc. and BluePoint Laboratories.
The recall was initiated because out-of-specification results were observed in the meta-chlorobenzoic acid impurity. This issue was identified in batches that were 18 months or older from the date of manufacture. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 26,496
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 (20)
- Lot #: a) 1612130
- 1612131
- Exp 11/18
- 1709986
- Exp 8/19
- 1711549
- Exp 10/19
- b) 1701171
- 1701174
- 1701175
- 1701176
- Exp 12/18
- 1705131
- 1705132
- 1705133
- Exp 4/19
- 1709985
- 17110257
- Exp 9/19
- 1712809
UPCs (2)
- 0369097875022
- 0369097876029
Distribution
Distributed nationwide across the United States.
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