September 4, 2019DrugsFDA
Alkermes Inc recalls Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 m
Hazard: Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
September 4, 2019DrugsFDA
Pfizer Inc. recalls RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-
Hazard: Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
September 4, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufac
Hazard: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
September 4, 2019DrugsFDA
Akorn, Inc. recalls Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 10
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
September 4, 2019DrugsFDA
Akorn, Inc. recalls Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactur
Hazard: Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
September 4, 2019DrugsFDA
Akorn, Inc. recalls Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactur
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
August 28, 2019DrugsFDA
SCA Pharmaceuticals, LLC recalls Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only
Hazard: Lack of Assurance of Sterility.
August 28, 2019DrugsFDA
Upsher Smith Laboratories, Inc. recalls Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Gr
Hazard: Failed Dissolution Specifications
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eye
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 m
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 eac
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Cl
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM IT
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoli
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle,
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 m
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 28, 2019DrugsFDA
Medtech Products, Inc. recalls Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL)
Hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
August 21, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15)
Hazard: Failed Dissolution Specifications
August 21, 2019DrugsFDA
American Health Packaging recalls Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed
Hazard: Failed Dissolution Specifications
August 21, 2019DrugsFDA
American Health Packaging recalls Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses
Hazard: Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
August 21, 2019DrugsFDA
Infusion Options, Inc. recalls FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-2
Hazard: Lack of Assurance of Sterility
August 21, 2019DrugsFDA
Infusion Options, Inc. recalls VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRIST
Hazard: Lack of Assurance of Sterility
August 21, 2019DrugsFDA
Infusion Options, Inc. recalls VINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the
Hazard: Lack of Assurance of Sterility
August 21, 2019DrugsFDA
Infusion Options, Inc. recalls VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE
Hazard: Lack of Assurance of Sterility
August 21, 2019DrugsFDA
Infusion Options, Inc. recalls TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUM
Hazard: Lack of Assurance of Sterility