Rosuvastatin Calcium Tablet, Film Coated
FDA Recall NDC 68788-7086
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Rosuvastatin Calcium (NDC 68788-7086). A significant event, classified as Class II, was initiated on Mar 23, 2023 by Preferred Pharmaceuticals Inc.. The reported reason for this action was: "cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
March 2023 Class II Recall: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall Number
Class II Ongoing
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Mar 23, 2023
Apr 12, 2023
a) 59 Bottles, b) 77 Bottles
Recall Profile & Regulatory Data
Event ID
91952
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
68788-7086-2Product
68788-7086-3Product
68788-7086-6Product
68788-7086-9Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
