Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
Reported: July 19, 2017 Initiated: June 22, 2017 #D-0974-2017
Product Description
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
Reason for Recall
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 12480 bottles
- Distribution
- Nationwide in the USA
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 12480 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2017. Severity: Low. Recall number: D-0974-2017.
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