Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.
Reported: March 8, 2023 Initiated: February 7, 2023 #D-0404-2023
Product Description
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- 63,247 bottles
- Distribution
- United States including Puerto Rico and Canada
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.. Recalled by Accord Healthcare, Inc.. Units affected: 63,247 bottles.
Why was this product recalled? ▼
CGMP Deviations: recalling drug products following an FDA inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2023. Severity: Moderate. Recall number: D-0404-2023.
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