Why it was recalled
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Product description
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Lot numbers, UPCs & expiration codes
Lot 17181491 Exp. Aug. 2021
Where it was sold
Nationwide in the USA
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-1120-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 25, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 2076 500-count Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1120-2019, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82461
- Address
- 750 Corporate Dr
- Code information
- Lot 17181491 Exp. Aug. 2021
- Postal code
- 07430-2009
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1120-2019
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 2076 500-count Bottles
- Termination date
- Sep 14, 2020
- Reason for recall
- Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2019