Recalls / Class II
Class IID-0832-2020
Product
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.
- Affected lot / code info
- Lot #: ATA318099C, Exp 12/2020
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.
Recalling firm
- Firm
- Graviti Pharmaceuticals Private Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Survey No. 621 Isnapur Village, Patancheru Mandal, Medak, N/A N/A, India
Distribution
- Quantity
- 29,056 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2020-01-28
- FDA classified
- 2020-02-07
- Posted by FDA
- 2020-02-12
- Terminated
- 2022-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0832-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.