FDA Recall
Terminated
Historical recordClass II
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.
by AstraZeneca Pharmaceuticals LP
- Reason
- Defective Delivery System: Some units have actuation counters set to a number other than 60.
- Published
- March 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
by Sagent Pharmaceuticals Inc
- Reason
- Cross contamination with other products: metronidazole
- Published
- March 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
by PharMEDium Services, LLC
- Reason
- Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
by PharMEDium Services, LLC
- Reason
- Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
by Teva Pharmaceuticals USA
- Reason
- Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
- Published
- March 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
by Tf Supplements
- Reason
- Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
by Tf Supplements
- Reason
- Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102
by Ecolab Inc
- Reason
- Subpotent drug
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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