Class I · High risk Ongoing
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Reason Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
PrimeZEN Black 6000 capsule
Reason 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 Completed
0.9% Sodium Chloride Injection
Reason 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 Completed
0.9% Sodium Chloride Injection
Reason 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 Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Picnic
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergy relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergyrelief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergy relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy ALLER-FEX
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
aller-ease
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Non-Drowsy Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Maximum Zone2 Topical Analgesic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Terminated
New & Improved Blue Gel Anesthetic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Ongoing
Fentanyl 500mcg
Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Class II · Moderate risk Ongoing
Tacrolimus Capsules
Reason Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 5 mg* 100-count bottle
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 4 mg* 100-count bottle
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 3 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 2 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.