Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 31 of 251
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
Reason: Lack of Assurance of Sterility
D-0586-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75
Reason: Lack of Assurance of Sterility
D-0594-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
Reason: Lack of Assurance of Sterility
D-0592-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Reason: Lack of Assurance of Sterility
D-0622-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
Reason: Lack of Assurance of Sterility
D-0619-2023 May 24, 2023 Vadodara, N/A
Sanofi-Aventis U.S. LLC
Class II Ongoing
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Reason: Lack of Assurance of Sterility: Malformed crimped collar seal
D-0575-2023 May 24, 2023 Bridgewater, NJ
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15
Reason: Lack of Assurance of Sterility
D-0599-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Reason: Lack of Assurance of Sterility
D-0601-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
Reason: Lack of Assurance of Sterility
D-0616-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
Reason: Lack of Assurance of Sterility
D-0597-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
Reason: Lack of Assurance of Sterility
D-0585-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
Reason: Lack of Assurance of Sterility
D-0580-2023 May 24, 2023 Vadodara, N/A
Apollo Care, LLC
Class II Ongoing
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
Reason: Lack of Assurance of Sterility
D-0632-2023 May 24, 2023 Columbia, MO
Astral SteriTech Private Ltd.
Class II Terminated
Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
Reason: Lack of Assurance of Sterility
D-0581-2023 May 24, 2023 Vadodara, N/A
Astral SteriTech Private Ltd.
Class II Terminated
Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
Reason: Lack of Assurance of Sterility
D-0618-2023 May 24, 2023 Vadodara, N/A
Baxter Healthcare Corporation
Class II Completed
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-04...
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
D-0543-2023 May 3, 2023 Deerfield, IL
Baxter Healthcare Corporation
Class II Completed
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-...
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
D-0542-2023 May 3, 2023 Deerfield, IL
Pharmacy Plus, Inc. dba Vital Care Compounder
Class II Ongoing
C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
Reason: Lack of assurance of sterility.
D-0538-2023 April 26, 2023 Hattiesburg, MS
Apollo Care
Class II Ongoing
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
D-0487-2023 April 5, 2023 Columbia, MO
Global Pharma Healthcare Private Limited
Class I Ongoing
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 ...
Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
D-0488-2023 March 29, 2023 Chennai, N/A
Pharmedica USA, LLC
Class I Ongoing
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
Reason: Non-Sterility
D-0456-2023 March 15, 2023 Phoenix, AZ
Apotex Corp.
Class II Completed
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 1...
Reason: Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact s...
D-0433-2023 March 15, 2023 Weston, FL
Nephron Sterile Compounding Center LLC
Class II Terminated
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcin...
Reason: Lack of Assurance of Sterility
D-0361-2023 March 8, 2023 West Columbia, SC
Nephron Sterile Compounding Center LLC
Class II Terminated
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Out...
Reason: Lack of Assurance of Sterility
D-0359-2023 March 8, 2023 West Columbia, SC
Nephron Sterile Compounding Center LLC
Class II Terminated
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcin...
Reason: Lack of Assurance of Sterility
D-0360-2023 March 8, 2023 West Columbia, SC