FDA Drug recall D-0372-2023

Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5

FDA Drug
Class II
terminated
Published 2023-03-08

On 2023-03-08 the FDA classified a Class II recall of Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0372-2023
Classification	Class II
Status	terminated
Initiated	2023-02-07
Published	2023-03-08
Last updated	2026-09-13 11:52 UTC
Company	Accord Healthcare
Distribution	PR

Product

Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, 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

upc	316729045155
upc	316729045179
ndc	16729-045-10
ndc	16729-045-15
ndc	16729-045-01
ndc	16729-045-16
ndc	16729-045-17
ndc	16729-044-10
ndc	16729-044-15
ndc	16729-044-01
ndc	16729-044-16
ndc	16729-044-17
ndc	16729-046-10
ndc	16729-046-15
ndc	16729-046-01
ndc	16729-046-16
ndc	16729-046-17
ndc	16729-047-10
ndc	16729-047-15
ndc	16729-047-01
ndc	16729-047-16
ndc	16729-047-17
code_info	Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R… Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, 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.

Other recalls by Accord Healthcare

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 167…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 1…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2761…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare

All Accord Healthcare recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0372-2023%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.