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Class IIDrug recallOngoing

Simvastatin Tablets recall

Recalled by Preferred Pharmaceuticals, Inc. of Anaheim, CA · FDA report 04/12/2023

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class II
Moderate
Status
Ongoing
Recall started
03/23/2023
Distribution
Nationwide

Reason for recall

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
Lot and code info
Lot: C2222P, D1522L, E3122D, G2522J, Exp 9/30/2023; Lot: J1222R, Exp 10/31/2023.
Quantity
82 Bottles of 90 Tablets
Recall number
D-0522-2023
Event ID
91952
Initiated by
Voluntary: Firm initiated

Where it was distributed

USA Nationwide

  • Nationwide

Recall timeline

  1. 03/23/2023Firm started the recall
  2. 04/06/2023FDA classified it as Class II
  3. 04/12/2023Published in the FDA enforcement report

All products in this recall

17 products under event 91952

More recalls from Preferred Pharmaceuticals

Frequently asked questions

Why was Simvastatin Tablets recalled?
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
What does Class II mean?
Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?
USA Nationwide
Is this recall still active?
The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 04/12/2023 · Do not rely on openFDA to make decisions regarding medical care