Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Reported: April 12, 2023 Initiated: March 23, 2023 #D-0524-2023
Product Description
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Details
- Recalling Firm
- Preferred Pharmaceuticals, Inc.
- Units Affected
- a) 305 Bottles, b) 72 Bottles, c) 617 Bottles
- Distribution
- USA Nationwide
- Location
- Anaheim, CA
Frequently Asked Questions
What product was recalled? ▼
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: a) 305 Bottles, b) 72 Bottles, c) 617 Bottles.
Why was this product recalled? ▼
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0524-2023.
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