💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,094 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Superpotent and Subpotent
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Fagron Compounding Services
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
GE Healthcare Ireland Limited
💊 Drugs Class I - Dangerous
Presence of particulate matter
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Superpotent and Subpotent
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
XTANT Medical Holdings
🏥 Medical Devices Class I - Dangerous
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
🏥 Medical Devices Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
🏥 Medical Devices Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Cook Incorporated
🏥 Medical Devices Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
🏥 Medical Devices Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
🏥 Medical Devices Class I - Dangerous
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.