Inspection by California Department of Public Health found that labeling did not properly declare milk.
All Recalls
95,025 total recalls in our database
ISOMORPH 28 PURE WHEY iSOLATE VANILLA MILKSHAKE DIETARY SUPPLEMENT NET WT. 2LB, UPC 6 49241 89886 5 & 5lb, UPC 6 49241 87836 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
Hi Tech Pharmaceuticals
During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
BTREX PLUS, Dietary Supplement 100 Caplets
Lopez Gonzalez Santana
CGMP Deviations: Presence of damaged tablets
Newly Weds B55713 breader X2, 50lbs bag
Newly Weds Foods
Foreign material
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Fresenius Medical Care, North America
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Subpotent Drug
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
SigmaPharm Laboratories
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Subpotent Drug
Lack of Assurance of Sterility
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
SigmaPharm Laboratories
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Failed Impurities/Degradation Specifications
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Presence of Particulate Matter: particulate matter identified as an insect in one vial.