Simvastatin 10 mg tablets recall: CGMP Deviations
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Why was Simvastatin 10 mg tablets recalled?
cGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) J0675206-011223, J0669260-121922, Exp. Date 01/31/2024; J0656820-103122, J0647161-091722, Exp. Date 09/30/2023 Exp. Date 11/30/2023; J0621491-052722, Exp. Date 06/30/2023; J0638138-080822, Exp. Date 08/31/2023, J0610887-041122, Exp. Date 04/30/2023. Lot # b) B1887315-100422, Exp. Date 02/28/2024; B1829906-083122, B1769715-071622, Exp. Date 09/30/2023; B1906605-101422, Exp. Date 02/28/2024; B1965118-111622, Exp. Date 02/28/2025.
- Product
- Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- Recalling firm
- RemedyRepack Inc.
- Quantity
- a) 1,262 bottles, b) 95 bottles
- Distribution
- RemedyRepack distributed product to consignees nationwide within the United States
- Recall date
- April 12, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)