💊 Drugs Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
💊 Drugs 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
💊 Drugs 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
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs 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
💊 Drugs 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
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs 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
💊 Drugs 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
💊 Drugs 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
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
💊 Drugs 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
💊 Drugs Class I - Dangerous
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
🏥 Medical Devices Class I - Dangerous
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.