Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-09-04FDA-DrugAkorn, Inc.Class IIIEptifibatide 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), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
- 2019-09-04FDA-DrugAkorn, Inc.Class IIIEptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
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.
- 2019-09-04FDA-DrugAkorn, Inc.Class IIIEptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
- 2019-08-28FDA-DrugSCA Pharmaceuticals, LLCClass IIKetamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Lack of Assurance of Sterility.
- 2019-08-28FDA-DrugUpsher Smith Laboratories, Inc.Class IIBexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
Failed Dissolution Specifications
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591 A Prestige Brands Company.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 30; Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Com
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3);
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.
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.
- 2019-08-28FDA-DrugMedtech Products, Inc.Class IIClear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.
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.
- 2019-08-21FDA-DrugMacleods Pharma Usa IncClass IITamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA
Failed Dissolution Specifications
- 2019-08-21FDA-DrugAmerican Health PackagingClass IICarbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
Failed Dissolution Specifications
- 2019-08-21FDA-DrugAmerican Health PackagingClass IIAspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIFERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIVINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIVINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIVELCADE 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 2.6 MG (1.04 ML) Sub Q SYRINGE; VELCADE 4 mg / 1.6 ml SQ SYRINGE; VELCADE 2.75 mg / 1.1 ml SQ SYRINGE; VELCADE 2.6 mg / 1.04 ml SQ SYRINGE VELCADE 1.7 mg / 0.68 ml SQ SYRINGE; VELCADE 3.5 mg / 1.4 ML SQ SYRINGE; VELCADE 2.2 mg / 0.88 ml SQ SYRINGE; VELCADE 2.33 MG/ 0.93 ML SUB-Q SYRINGE; VELCADE 2.4 MG/ 0.96 ML SUB-Q SYRINGE VELCADE 2.63 MG/ 1.052 ML SUB-Q SYRINGE, Rx Only, I
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IITRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TRASTUZUMAB 444 MG / 250 ml NS IVPB; TRASTUZUMAB 634 MG / 250 ML NS IVPB; TRASTUZUMAB 330 MG / 250 ML NS IVPB; TRASTUZUMAB 781 MG / 250 ML NS IVPB; TRASTUZUMAB 376 mg / 250 ML NS IVPB; TRASTUZUMAB 114 MG
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IITOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IISOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IISodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium Sulfate 2 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
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