💊 Drugs Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
All Recalls
95,018 total recalls in our database
AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g)
Family Dollar Stores
💊 Drugs Class I - Dangerous
cGMP deviations: product stored outside of labeled temperature requirements.
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Nephron Sterile Compounding Center
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
Nephron Sterile Compounding Center
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Nephron Sterile Compounding Center
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
Family Dollar Stores
💊 Drugs Class I - Dangerous
cGMP deviations: product stored outside of labeled temperature requirements.
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Nephron Sterile Compounding Center
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ion Beam Applications S.A.
🏥 Medical Devices Class I - Dangerous
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
🏥 Medical Devices Class I - Dangerous
Incorrect product labeling.
🏥 Medical Devices Class I - Dangerous
Software anomaly was identified.
3.2MM Pellet Insertion Tray Catalog Number: B9743
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Becton, Dickinson and Company, BD Biosciences
🏥 Medical Devices Class I - Dangerous
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
3,65 m Extension Set with Luer-lock Connector
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
15 Liters Drain Bag
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Nerve Block Tray Catalog Number: 8415
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Single Shot Epidural Tray Catalog Number: 8417
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products