Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-08-29FDA-DrugPreferred Pharmaceuticals, IncClass IIValsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-22FDA-DrugRemedyRepack Inc.Class IIValsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugRemedyRepack Inc.Class IIValsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugRemedyRepack Inc.Class IIValsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugOrexigen Therapeutics, Inc.Class IIIContrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.
Defective Container: Customer complaints of punctures in the bottle.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPapav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIP/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIP/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIAcetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIMedroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIVitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIDehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIMorphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IITriple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIAvastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIDMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIAtropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAtorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
- 2018-08-22FDA-DrugThe Hain Celestial Group, Inc. - Worldwide HQClass IIalba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
Microbial Contamination of a Non-Sterile Product
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