FDA Recall D-0519-2023

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Class II Ongoing 1148 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Rosuvastatin 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 Healthcare, Inc., Durham, NC 27703.

Lot / code: a) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K0222N, Exp. Date: 6/30/2024; Lot: L2322D and Lot: L2822J, Exp. Date:7/31/2025.

Quantity: a) 59 Bottles, b) 77 Bottles

Reason for recall

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

Recall record

Recall number: D-0519-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2023-03-23
Classified by FDA Center: 2023-04-06
FDA published: 2023-04-12
Recalling firm: Preferred Pharmaceuticals, Inc.
Firm location: Anaheim, CA

Drug identification

Brand name(s): ROSUVASTATIN CALCIUM
Generic name(s): ROSUVASTATIN CALCIUM
Manufacturer(s): Preferred Pharmaceuticals Inc.
NDC(s): 68788-7086
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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