Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services…
Reason Lack of assurance of sterility:
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class I · High risk Terminated
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC#…
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class III · Low risk Terminated
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%…
Reason Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk Terminated
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use…
Reason Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class III · Low risk Terminated
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only…
Reason Subpotent: Out of Specification result observed for low assay
Class III · Low risk Terminated
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%…
Reason Incorrect/Undeclared Excipients.
Class II · Moderate risk Terminated
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC…
Reason Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class III · Low risk Terminated
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health…
Reason Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class II · Moderate risk Terminated
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by…
Reason Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class III · Low risk Terminated
Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6…
Reason Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Class I · High risk Terminated
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code…
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product…
Class II · Moderate risk Terminated
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New…
Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets…
Class I · High risk Terminated
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New…
Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets…
Class II · Moderate risk Terminated
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for…
Reason CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.