Class II · Moderate risk Terminated
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only…
Reason Stability data does not support expiry.
Is Sage recalled?
192 FDA recalls mention Sage. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sage.
Class II · Moderate risk Terminated
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON…
Reason Subpotent drug.
Class II · Moderate risk Terminated
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON…
Reason Stability data does not support expiry.
Class III · Low risk Terminated
Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by…
Reason Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class II · Moderate risk Terminated
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection…
Reason Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site…
Class II · Moderate risk Terminated
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection…
Reason Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site…
Class II · Moderate risk Terminated
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only…
Reason Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect…
Class II · Moderate risk Terminated
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE…
Reason Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Class I · High risk Terminated
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon…
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk Terminated
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc…
Reason Superpotent Drug: Product contains twice the stated amount of midazolam.
Class II · Moderate risk Terminated
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For…
Reason Lack of Assurance of Sterility; leaking of premix bags
Class II · Moderate risk Terminated
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150…
Reason Failed Tablet Specifications: Broken Tablets Present.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b)…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only…
Reason Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Class II · Moderate risk Terminated
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only…
Reason CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation…
Class II · Moderate risk Terminated
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured…
Reason Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time…
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