RecallRadar

FDA Drug recall D-0412-2023

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3

On 2023-03-08 the FDA classified a Class II recall of Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0412-2023
ClassificationClass II
Statusterminated
Initiated2023-02-07
Published2023-03-08
Last updated2026-09-13 11:52 UTC
CompanyAccord Healthcare
DistributionPR

Product

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; 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

upc316729007153
upc316729007177
ndc16729-005-10
ndc16729-005-12
ndc16729-005-15
ndc16729-005-17
ndc16729-006-10
ndc16729-006-12
ndc16729-006-15
ndc16729-006-17
ndc16729-007-10
ndc16729-007-12
ndc16729-007-15
ndc16729-007-17
ndc16729-156-10
ndc16729-156-15
ndc16729-156-17
ndc16729-004-10
ndc16729-004-12
ndc16729-004-15
ndc16729-004-17
code_info
Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103…Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024

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-0412-2023%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.