Checked
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
- 03/23/2023Firm started the recall
- 04/06/2023FDA classified it as Class II
- 04/12/2023Published in the FDA enforcement report
All products in this recall
17 products under event 91952
- D-0511-2023Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
- D-0512-2023Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured...
- D-0513-2023Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
- D-0514-2023Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
- D-0515-2023Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
- D-0516-2023Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord...
- D-0517-2023Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
- D-0518-2023Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC...
- D-0519-2023Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord...
- D-0520-2023Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
- D-0521-2023Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
- D-0522-2023Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9 This page
- D-0523-2023Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
- D-0524-2023Simvastatin 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...
- D-0525-2023Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC...
- D-0526-2023Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
- D-0527-2023Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
More recalls from Preferred Pharmaceuticals
- Class IIDrugOngoing10/14/2026Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro...Preferred Pharmaceuticals, Inc. · Failed Content Uniformity Specifications
- Class IIDrugOngoing04/15/2026Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5...Preferred Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- Class IIDrugOngoing12/24/2025Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited...Preferred Pharmaceuticals, Inc. · Defective container: Preferred Pharmaceuticals received a letter...
- Class IIDrugOngoing05/07/2025Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark...Preferred Pharmaceuticals, Inc. · cGMP Deviations
- Class IIDrugOngoing09/04/2024Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's...Preferred Pharmaceuticals, Inc. · Failed Impurities/Degradation Specifications - at 18-month...
- Class IIDrugOngoing05/29/2024Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC...Preferred Pharmaceuticals, Inc. · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above...
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