Class III · Low risk Terminated
ESTRADIOL 20mg PELLET
Reason Labeling: Incorrect or Missing Lot and/or Exp Date.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class III · Low risk Terminated
Maxzide-25
Reason Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc99m Medronate
Reason Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk Terminated
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Reason Superpotent and Subpotent
Class I · High risk Terminated
Naloxone Hydrochloride Injection
Reason Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.45% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
Fluticasone propionate Nasal Spray
Reason Presence of foreign substance: glass particles
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Resuspension problems: Out of specification for appearance and resuspendability.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class II · Moderate risk Terminated
Acne Shave 3 Step Shaving System
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
Acne Shave
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
Acne Shave Post-Shave Moisturizer
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
X-Jow
Reason CGMP Deviations: products may be contaminated with bacteria.
Class I · High risk Terminated
Allergan Taytulla Softgel Capsules
Reason Contraceptive Tablets Out of Sequence.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets
Reason Labeling: Missing Label
Class II · Moderate risk Terminated
READYFLUSH PROTECT with Dimethicone
Reason Microbial Contamination of a Non-Sterile Product.
Class II · Moderate risk Terminated
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial…
Reason Lack of sterility assurance.