Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Failed viscosity specification - product was below specificcation
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02
Best Brands Consumer Products
Class I - Dangerous
Chemical Contamination; FDA analysis found product to contain methanol
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class I - Dangerous
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP deviations: tablets cracking
The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02
Best Brands Consumer Products
Class I - Dangerous
Chemical Contamination; FDA analysis found product to contain benzene
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
Failed Dissolution Specifications
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
SCA Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
Subpotent Drug: Out of specification for assay.
Class I - Dangerous
Labeling: Missing label on the vial
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Olympia Compounding Pharmacy
Class I - Dangerous
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.
Olympia Compounding Pharmacy
Class I - Dangerous
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated