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.
Reported: February 12, 2020 Initiated: January 28, 2020 #D-0832-2020
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.
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.
Details
- Recalling Firm
- Graviti Pharmaceuticals Private Limited
- Units Affected
- 29,056 bottles
- Distribution
- Nationwide in the USA.
- Location
- Medak, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Graviti Pharmaceuticals Private Limited. Units affected: 29,056 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2020. Severity: Moderate. Recall number: D-0832-2020.
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