Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class II · Moderate risk
Warfarin Sodium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Purely Soothing MSM Nasal Spray
CGMP Deviations
Class I · High risk
Purely Soothing 15% MSM Drops
Non-Sterility
Class I · High risk
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Class I · High risk
PrimeZEN Black 6000 capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergyrelief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy ALLER-FEX
Failed Impurities/Degradation Specifications
Class II · Moderate risk
aller-ease
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Non-Drowsy Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Maximum Zone2 Topical Analgesic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk
New & Improved Blue Gel Anesthetic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.