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.
Product description
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
Lot numbers, UPCs & expiration codes
Lot # G702459, Exp 2/20
Where it was sold
Product was distributed throughout the United States, including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0092-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 17, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Limited
Original FDA data
Every field from FDA enforcement report D-0092-2018, exactly as published.
Show all FDA fields
- City
- Vasco Da Gama
- Status
- Terminated
- Country
- India
- Event ID
- 78566
- Address
- 15 - B I Phase 1a
- Address (line 2)
- I D C Verna Industrial Road
- Code information
- Lot # G702459, Exp 2/20
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0092-2018
- Classification
- Class II
- Recalling firm
- Lupin Limited
- Termination date
- Mar 15, 2019
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
- Recall initiation date
- Nov 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2017