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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Filters
Showing 10,601–10,620 of 17,974 drug recalls
Drug RecallTerminatedHistorical recordClass I
EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
by Bristol-Myers Squibb Company
Reason
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Recall initiated
May 25, 2017
Reported by FDA
July 19, 2017
Distribution
Nationwide in the USA and Puerto Rico to physician offices.
VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
by Phillips Co.
Reason
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.
StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
by Phillips Co.
Reason
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.
StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
by Phillips Co.
Reason
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.
Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11
by Phillips Co.
Reason
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.
TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
by Phillips Co.
Reason
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.
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
by Phillips Co.
Reason
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.
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
by G & W Laboratories, Inc.
Reason
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
by Lantheus MI Radipharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
