Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
💉
Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
Fagron Compounding Services LLC
Class I - Dangerous
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Class I - Dangerous
Presence of Foreign Substance: possibility of the presence of metal in the product.
Class I - Dangerous
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class I - Dangerous
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class I - Dangerous
GMP Deviations; product may not meet cGMP requirements
Class I - Dangerous
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class I - Dangerous
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class I - Dangerous
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
Valeant Pharmaceuticals North America
Class I - Dangerous
Discoloration.
Class I - Dangerous
Discoloration.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class I - Dangerous
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class I - Dangerous
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection