Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
FDA Drug Recalls
17,898 recalls, newest first
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.
Class II · Moderate risk Terminated
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL…
Reason Lack of sterility assurance.