Class II · Moderate risk
Kit for the Preparation of Technetium Tc99m Medronate
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Superpotent and Subpotent
Class I · High risk
Naloxone Hydrochloride Injection
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class II · Moderate risk
5% Dextrose Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.45% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
Fluticasone propionate Nasal Spray
Presence of foreign substance: glass particles
Class II · Moderate risk
Atorvastatin Calcium Tablets
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
Nystatin Oral Suspension
Resuspension problems: Out of specification for appearance and resuspendability.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class II · Moderate risk
Acne Shave 3 Step Shaving System
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave Post-Shave Moisturizer
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
X-Jow (menthol USP)
CGMP Deviations: products may be contaminated with bacteria.
Class I · High risk
Allergan Taytulla Softgel Capsules
Contraceptive Tablets Out of Sequence.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Labeling: Missing Label
Class II · Moderate risk
READYFLUSH PROTECT with Dimethicone
Microbial Contamination of a Non-Sterile Product.
Class II · Moderate risk
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Lack of sterility assurance.
Class II · Moderate risk
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial…
Lack of sterility assurance.
Class II · Moderate risk
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Lack of sterility assurance.