Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
New England Life Care, Inc.
Class I - Dangerous
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.