Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 50 of 251
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Reason: Lack of Assurance of Sterility
D-0415-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 054...
Reason: Lack of Assurance of Sterility.
D-0400-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
Reason: Lack of Assurance of Sterility
D-0416-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 054...
Reason: Lack of Assurance of Sterility
D-0423-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (co...
Reason: Lack of Assurance of Sterility
D-0405-2022 February 2, 2022 Colchester, VT
Teva Pharmaceuticals USA
Class II Terminated
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceutic...
Reason: Lack of Assurance of Sterility
D-0370-2022 January 19, 2022 Parsippany, NJ
Exela Pharma Sciences LLC
Class II Terminated
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Reason: Lack of Assurance of Sterility
D-0369-2022 January 19, 2022 Lenoir, NC
Teva Pharmaceuticals USA
Class II Terminated
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-...
Reason: Lack of Assurance of Sterility
D-0371-2022 January 19, 2022 Parsippany, NJ
SterRx, LLC
Class II Terminated
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
Reason: Lack of Assurance of Sterility
D-0318-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
Reason: Lack of Assurance of Sterility
D-0317-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
Reason: Lack of Assurance of Sterility
D-0321-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Reason: Lack of Assurance of Sterility
D-0323-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
Reason: Lack of Assurance of Sterility
D-0304-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
Reason: Lack of Assurance of Sterility
D-0303-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
Reason: Lack of Assurance of Sterility
D-0301-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
Reason: Lack of Assurance of Sterility
D-0320-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
Reason: Lack of Assurance of Sterility
D-0324-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
Reason: Lack of Assurance of Sterility
D-0305-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
Reason: Lack of Assurance of Sterility
D-0314-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Reason: Lack of Assurance of Sterility
D-0325-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
Reason: Lack of Assurance of Sterility
D-0319-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
Reason: Lack of Assurance of Sterility
D-0315-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
Reason: Lack of Assurance of Sterility
D-0313-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
Reason: Lack of Assurance of Sterility
D-0302-2022 January 5, 2022 Plattsburgh, NY
SterRx, LLC
Class II Terminated
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
Reason: Lack of Assurance of Sterility
D-0310-2022 January 5, 2022 Plattsburgh, NY