Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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
Class I - Dangerous
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class I - Dangerous
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
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class I - Dangerous
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
Class I - Dangerous
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
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
Class I - Dangerous
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class I - Dangerous
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
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I - Dangerous
Subpotent and Presence of Particulates .
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Preferred Pharmaceuticals
Class I - Dangerous
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class I - Dangerous
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.