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 Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC ... 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 Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3... 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 Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3... 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 Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3... 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 BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, 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 BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 ... 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 BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord He... 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 BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord He... 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 BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Hea... 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 Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 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 Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 ... 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 Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharm... 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 Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, 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 Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, 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 Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, 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 Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 1672... 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 Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 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 Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 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 Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41... 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 Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16...
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.