Recalls / Class III
Class IIID-0618-2018
Product
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
- Brand name
- Bupropion Hydrochloride (sr)
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 69097-877, 69097-878, 69097-879
- FDA application
- ANDA206674
- Affected lot / code info
- Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
Why it was recalled
Failed Dissolution Specifications; during stability testing
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- Cipla USA Inc.,
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Oser Ave, N/A, Hauppauge, New York 11788-3811
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-03-15
- FDA classified
- 2018-04-04
- Posted by FDA
- 2018-04-11
- Terminated
- 2021-09-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0618-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.