RecallRadar

FDA Drug recall D-0498-2023

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repack…

On 2023-04-12 the FDA classified a Class II recall of Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repack… by Remedyrepack, citing cGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0498-2023
ClassificationClass II
Statusterminated
Initiated2023-03-20
Published2023-04-12
Last updated2026-09-13 11:52 UTC
CompanyRemedyrepack
DistributionUS

Product

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Reason

cGMP Deviations

Identifiers

code_info
Lot #: a) J0659819-110922, Exp. Date 11/30/2023; J0649932-093022, J0649917-093022 Exp. Date 10/31/2023, B2010060-121222…Lot #: a) J0659819-110922, Exp. Date 11/30/2023; J0649932-093022, J0649917-093022 Exp. Date 10/31/2023, B2010060-121222, Exp. Date 03/31/24 Lot #: b) B1708575-060122, Exp. Date 05/31/2023; B1879236-092922, Exp. Date 12/31/2023

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-0498-2023%22

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