Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
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Prescription Drugs
💊 Drugs • 12,141 recalls
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brookfield Prescription Center Inc.
Class I - Dangerous
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class I - Dangerous
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
Forest Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brookfield Prescription Center Inc.
Class I - Dangerous
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
Caraco Pharmaceutical Laboratories
Class I - Dangerous
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
Pfizer Us Pharmaceutical Group
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Class I - Dangerous
Subpotent Drug.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.