Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Product description
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
Lot numbers, UPCs & expiration codes
Lot #: ATA318099C, Exp 12/2020
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-0832-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 28, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- 29,056 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Graviti Pharmaceuticals Private Limited
Original FDA data
Every field from FDA enforcement report D-0832-2020, exactly as published.
Show all FDA fields
- City
- Medak
- Status
- Terminated
- Country
- India
- Event ID
- 84814
- Address
- Survey No. 621 Isnapur Village
- Address (line 2)
- Patancheru Mandal
- Code information
- Lot #: ATA318099C, Exp 12/2020
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0832-2020
- Classification
- Class II
- Recalling firm
- Graviti Pharmaceuticals Private Limited
- Product quantity
- 29,056 bottles
- Termination date
- Nov 29, 2022
- Reason for recall
- Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2020