Class II · Moderate risk Terminated
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
FDA Drug Recalls
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Class II · Moderate risk Terminated
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class I · High risk Terminated
NitroGlycerin
Reason Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk Terminated
NitroGlycerin
Reason Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk Terminated
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Reason Subpotent Drug: found to be below the specification for labeled assay.
Class II · Moderate risk Terminated
VenomX
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.
Class II · Moderate risk Terminated
StaphWash+Plus+ Skin Protectant
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.
Class II · Moderate risk Terminated
StingMed Insect bites Skin Protectant. Zinc acetate
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.
Class II · Moderate risk Terminated
Diabecline brand Topical Ointment First Aid Antibiotic
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.
Class II · Moderate risk Terminated
TetraStem brand Topical Ointment First Aid Antibiotic
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.
Class II · Moderate risk Terminated
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
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.
Class I · High risk Terminated
Andropharm M1 Alpha
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk Terminated
Andropharm Sten Z
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class II · Moderate risk Terminated
NasalCrom
Reason CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class I · High risk Terminated
EliquisTablets 5mg
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.
Class III · Low risk Terminated
Walgreens Daytime and Nighttime Cold & Flu
Reason Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Class II · Moderate risk Terminated
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%
Reason Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Class III · Low risk Terminated
G & W Clobetasol Propionate Ointment 0.05%
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.
Class II · Moderate risk Terminated
Chlorhexidine Gluconate 0.12% Oral Rinse
Reason CGMP Deviations
Class II · Moderate risk Terminated
Doxycycline Hyclate USP
Reason Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules USP
Reason Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Class II · Moderate risk Terminated
methylcobalamin 1mg/1mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Option 2
Reason Defective Container: Carton is missing the tablet blister strip and tablet.
Class I · High risk Terminated
Paliperidone Extended-Release Tablets
Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class III · Low risk Terminated
BuPROPion HCL Tablets
Reason Failed Moisture Limits: Product tested out-of-specification for moisture content.