Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
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.
Class II · Moderate risk
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL…
Lack of sterility assurance.