💊 Drugs Class I - Dangerous
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
💊 Drugs Class I - Dangerous
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification impurity test results.
💊 Drugs Class I - Dangerous
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
💊 Drugs Class I - Dangerous
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
Axcentria Pharmaceuticals
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification impurity test results.
💊 Drugs Class I - Dangerous
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification impurity test results.
🏥 Medical Devices Class I - Dangerous
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Potential for sample misidentification.
ACL TOP (Base), automated coagulation laboratory instrument.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Potential for sample misidentification.
ACL TOP 700, automated coagulation laboratory instrument.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Potential for sample misidentification.
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
🏥 Medical Devices Class I - Dangerous
Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.
🏥 Medical Devices Class I - Dangerous
A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.