Class II · Moderate risk Ongoing
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B…
Reason Labelling: Illegible label
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only…
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only…
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only…
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
Class II · Moderate risk Ongoing
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk Ongoing
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC…
Reason Failed tablet specifications.
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA…
Reason Crystallization; identified as Buprenorphine free base
Class II · Moderate risk Ongoing
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen…
Reason Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk Ongoing
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only…
Reason Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk Ongoing
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius…
Reason Lack of Assurance of Sterility