Recalls / Class II
Class IID-0092-2018
Product
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
- Brand name
- Pravastatin Sodium
- Generic name
- Pravastatin Sodium
- Active ingredient
- Pravastatin Sodium
- Route
- Oral
- NDCs
- 68180-485, 68180-486, 68180-487, 68180-488
- FDA application
- ANDA077917
- Affected lot / code info
- Lot # G702459, Exp 2/20
Why it was recalled
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Recalling firm
- Firm
- Lupin Limited
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 - B I Phase 1a, I D C Verna Industrial Road, Vasco Da Gama, N/A N/A, India
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
Timeline
- Recall initiated
- 2017-11-17
- FDA classified
- 2017-11-21
- Posted by FDA
- 2017-11-29
- Terminated
- 2019-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0092-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.