RecallRadar

FDA Drug recall D-0421-2023

Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0

On 2023-03-08 the FDA classified a Class II recall of Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0421-2023
ClassificationClass II
Statusterminated
Initiated2023-02-07
Published2023-03-08
Last updated2026-09-13 11:52 UTC
CompanyAccord Healthcare
DistributionPR

Product

Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 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

upc316729008150
upc316729008167
ndc16729-008-15
ndc16729-008-16
ndc16729-008-17
ndc16729-009-15
ndc16729-009-16
ndc16729-009-17
ndc16729-010-15
ndc16729-010-16
ndc16729-010-17
ndc16729-011-15
ndc16729-011-16
ndc16729-011-17
code_infoBatches: a) R2201093, Exp. Date 4/30/2024; b) R2201222, R2201231, Exp. Date 4/30/2024;

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-0421-2023%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.