FDA Recall
Terminated
Historical recordClass II
GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
by Advanced Physician Solutions, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy.
by Stroheckers Inc Pharmacy
- Reason
- Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: One lot exceeded the mechanical peel specification
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
by Boehringer Ingelheim Roxane Inc
- Reason
- Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
- Published
- May 27, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
by Alvogen, Inc
- Reason
- Failed Dissolution Specification; 6 month time point
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
View recall →
FDA Recall
Terminated
Historical 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
View recall →
FDA Recall
Terminated
Historical 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
Terminated
Historical 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 →
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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