Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-04-27FDA-DrugVIRGIN SCENT INCClass IIartnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
- 2022-04-27FDA-DrugVIRGIN SCENT INCClass Iartnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IISermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IIPT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IIMelanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IILL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IIIpamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IIBPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingClass IIARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-27FDA-DrugMylan Pharmaceuticals IncClass IIRifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
- 2022-04-27FDA-DrugPreferred Pharmaceuticals, Inc.Class IIDiclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
- 2022-04-20FDA-DrugPreferred Pharmaceuticals, Inc.Class IIEconazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
- 2022-04-20FDA-DrugPreferred Pharmaceuticals, Inc.Class IIPreferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09
Out of specification results observed in dissolution during long term stability testing.
- 2022-04-20FDA-DrugPreferred Pharmaceuticals, Inc.Class IIClobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
- 2022-04-20FDA-DrugAurobindo Pharma USA Inc.Class IIICyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Subpotent Drug: Out of Specification results for Assay
- 2022-04-20FDA-DrugTeva Pharmaceuticals USA IncClass IIDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
Presence of Particulate Matter: Product was found to contain silica and iron oxide
- 2022-04-13FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIICequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- 2022-04-13FDA-DrugAdamis Pharmaceuticals CorporationClass ISYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02.
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- 2022-04-13FDA-DrugAdamis Pharmaceuticals CorporationClass ISYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- 2022-04-13FDA-DrugMacleods Pharma Usa IncClass IIIRisedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.
FAILED CONTENT UNIFORMITY SPECIFICATIONS
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIquinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIquinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIquinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugPfizer Inc.Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- 2022-04-13FDA-DrugSandoz, IncClass IIOrphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- 2022-04-13FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIMethylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
Subpotent
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