D-0527-2023 Class II Ongoing

Recalled by Preferred Pharmaceuticals, Inc. — Anaheim, CA

FDA drug recall D-0527-2023 was initiated by Preferred Pharmaceuticals, Inc. on March 23, 2023 and is designated Class II. Reason for recall: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. The recall status is ongoing. Affected quantity: 15 Bottles.

Recall Details

Product Type
Drugs
Report Date
April 12, 2023
Initiation Date
March 23, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 Bottles

Product Description

Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

Reason for Recall

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

Distribution Pattern

USA Nationwide

Code Information

Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.