Records and reported status
Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 1... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 1... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 167... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 167... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 1... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord H... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcar... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., ... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15,... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthca... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healt... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Health... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, ... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, I... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc....
Reasons in these listed records CGMP Deviations: recalling drug products following an FDA inspection. These examples come from this result page and are not a ranking of every recall reason.
Checking Accord Healthcare, Inc. Is there a recall on accord healthcare, inc. right now? This archive contains 103 records, including 25 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.