Simvastatin 40mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Brand
RemedyRepack Inc.
Lot Codes / Batch Numbers
Lot # a): J0656821-103122, Exp. Date 11/30/2023, J0638547-080922, Exp. Date 08/31/2023, J0633575-071822, Exp. Date 07/31/2023 Lot #: b): B1965081-111622, Exp. Date 03/31/2025, B1857922-091922, B1765298-071322, B1786319-072922, B1706842-053122, Exp. Date 04/30/2023, B2003311-120822, Exp. Date 04/30/2025, B1955679-111122, Exp. Date 02/28/2025, B1878942-092922, Exp. Date 11/30/2024, B1823203-082622. Exp. Date 10/31/2024, B1706843-053122, Exp. Date 05/31/2023
Products Sold
Lot # a): J0656821-103122, Exp. Date 11/30/2023; J0638547-080922, Exp. Date 08/31/2023; J0633575-071822, Exp. Date 07/31/2023 Lot #: b): B1965081-111622, Exp. Date 03/31/2025; B1857922-091922, B1765298-071322, B1786319-072922, B1706842-053122, Exp. Date 04/30/2023; B2003311-120822, Exp. Date 04/30/2025; B1955679-111122, Exp. Date 02/28/2025; B1878942-092922, Exp. Date 11/30/2024; B1823203-082622. Exp. Date 10/31/2024; B1706843-053122, Exp. Date 05/31/2023
RemedyRepack Inc. is recalling Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottl due to cGMP Deviations. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026