RecallRadar

FDA Drug recall D-0371-2023

Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8

On 2023-03-08 the FDA classified a Class II recall of Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0371-2023
ClassificationClass II
Statusterminated
Initiated2023-02-07
Published2023-03-08
Last updated2026-09-13 11:52 UTC
CompanyAccord Healthcare
DistributionPR

Product

Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.

Reason

CGMP Deviations: recalling drug products following an FDA inspection.

Identifiers

upc316729044158
upc316729044172
ndc16729-045-10
ndc16729-045-15
ndc16729-045-01
ndc16729-045-16
ndc16729-045-17
ndc16729-044-10
ndc16729-044-15
ndc16729-044-01
ndc16729-044-16
ndc16729-044-17
ndc16729-046-10
ndc16729-046-15
ndc16729-046-01
ndc16729-046-16
ndc16729-046-17
ndc16729-047-10
ndc16729-047-15
ndc16729-047-01
ndc16729-047-16
ndc16729-047-17
code_info
Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R…Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R2200223, Exp. Date 1/31/2024; R2200795, R2200713, R2200701, R2200711, R2200712, R2200756, R2200757, R2200754, R2200755, Exp. Date 5/31/2024; R2200945, R2200943, Exp. Date 6/30/2024;

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-0371-2023%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.