FDAMarch 15, 2021drug

BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What to do

FDA enforcement status: Terminated

Brands named

cardinal healthcardinal

UPCs

47781035603

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

CPSCDiamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging2026-07-02
FDABuprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-052026-06-12
FDAPrimidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-112026-05-01
FDAPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-112026-05-01
FDAVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-082026-05-01
CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
FDAAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-012026-04-30
FDAOptase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.2026-04-20

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