FDA Recall
TerminatedTerminated: April 7, 2017Historical recordClass III
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
by Apotex Inc.
- Reason
- Subpotent drug
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 7, 2017Historical recordClass III
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
by Apotex Inc.
- Reason
- Subpotent drug
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 14, 2017Historical recordClass III
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
by Cipla Limited
- Reason
- Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
- Published
- May 20, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 3, 2016Historical recordClass III
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30
by Medtech Products, Inc.
- Reason
- Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
- Published
- May 20, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 19, 2016Historical recordClass I
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
by Hospira Inc.
- Reason
- Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: June 5, 2018Historical recordClass II
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
by Fallon Wellness Pharmacy, L.L.C.
- Reason
- Lack of assurance of sterility
- Published
- May 20, 2015
- Distribution
- New York
View recall →
FDA Recall
TerminatedTerminated: January 26, 2017Historical recordClass II
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
by Mission Pharmacal Co
- Reason
- Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 26, 2017Historical recordClass II
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
by Mission Pharmacal Co
- Reason
- Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 13, 2018Historical recordClass II
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.
by Janssen Pharmaceuticals, Inc.
- Reason
- Subpotent Drug
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 27, 2017Historical recordClass II
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
by Akorn, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 27, 2017Historical recordClass II
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
by Akorn, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
- Published
- May 20, 2015
- 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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