Drug Recall
Terminated
Historical recordClass III
Valsartan 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
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Recall initiated
- August 14, 2018
- Reported by FDA
- August 29, 2018
- Distribution
- Product was distributed throughout the United States to wholesalers and retailers.
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan 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
by RemedyRePack Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- August 10, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed to three customers in FL and VA.
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan 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
by RemedyRePack Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- August 10, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed to three customers in FL and VA.
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan 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
by RemedyRePack Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- August 10, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed to three customers in FL and VA.
View recall →
Drug Recall
Terminated
Historical recordClass III
Contrave (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.
by Orexigen Therapeutics, Inc.
- Reason
- Defective Container: Customer complaints of punctures in the bottle.
- Recall initiated
- August 9, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- July 18, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Indiana
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- July 18, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Indiana
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- July 18, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Indiana
View recall →
Drug Recall
Terminated
Historical recordClass II
Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Recall initiated
- July 18, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Indiana
View recall →
Drug Recall
Terminated
Historical recordClass II
Papav 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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
P/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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
PRO/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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
PRASH 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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
P/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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
Dehydrated 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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
Drug Recall
Terminated
Historical recordClass II
PR/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.
by Ranier's Compounding Laboratory
- Reason
- Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- Recall initiated
- July 25, 2018
- Reported by FDA
- August 22, 2018
- Distribution
- Product was distributed within the state of Pennsylvania.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
