FDA Drug recall D-0491-2023

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repac…

FDA Drug
Class II
terminated
Published 2023-04-12

On 2023-04-12 the FDA classified a Class II recall of Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repac… by Remedyrepack, citing cGMP Deviations.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0491-2023
Classification	Class II
Status	terminated
Initiated	2023-03-20
Published	2023-04-12
Last updated	2026-09-13 11:52 UTC
Company	Remedyrepack
Distribution	US

Product

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Reason

cGMP Deviations

Identifiers

code_info	Lot #: a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/… Lot #: a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/31/2023; J0654076-101822, J0654076-101822, Exp. Date 11/30/2023; J0642765-082922, Exp. Date 09/30/2023 Lot #: b) B1672408-050322, B1765902-071322, B1769634-071622, Exp. Date 04/30/2023; B1776907-072122, Exp. Date 09/30/2023; B1836636-090322, Exp. Date 11/30/2023; B1870344-092422, Exp. Date 01/31/2024; B1908452-101522, B1966455-111722, B2043099-010423, Exp. Date 05/31/2024

code_info

Lot #: a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/…

Lot #: a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/31/2023; J0654076-101822, J0654076-101822, Exp. Date 11/30/2023; J0642765-082922, Exp. Date 09/30/2023 Lot #: b) B1672408-050322, B1765902-071322, B1769634-071622, Exp. Date 04/30/2023; B1776907-072122, Exp. Date 09/30/2023; B1836636-090322, Exp. Date 11/30/2023; B1870344-092422, Exp. Date 01/31/2024; B1908452-101522, B1966455-111722, B2043099-010423, Exp. Date 05/31/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0491-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.