Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 67 of 251
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angel...
Reason: Lack of Assurance of Sterility
D-0951-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood...
Reason: Lack of Assurance of Sterility
D-0972-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwoo...
Reason: Lack of Assurance of Sterility
D-0975-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx on...
Reason: Lack of Assurance of Sterility
D-0969-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 712...
Reason: Lack of Assurance of Sterility
D-0959-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3
Reason: Lack of Assurance of Sterility
D-0982-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
Reason: Lack of Assurance of Sterility
D-0941-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 712...
Reason: Lack of Assurance of Sterility
D-0980-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283...
Reason: Lack of Assurance of Sterility
D-0935-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1
Reason: Lack of Assurance of Sterility
D-0947-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; N...
Reason: Lack of Assurance of Sterility
D-0957-2020 March 11, 2020 Los Angeles, CA
Pfizer Inc.
Class II Terminated
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
Reason: Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange colo...
D-0995-2020 March 11, 2020 New York, NY
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3
Reason: Lack of Assurance of Sterility
D-0946-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharm...
Reason: Lack of Assurance of Sterility
D-0962-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Po...
Reason: Lack of Assurance of Sterility
D-0942-2020 March 11, 2020 Los Angeles, CA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Class II Terminated
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles...
Reason: Lack of Assurance of Sterility
D-0956-2020 March 11, 2020 Los Angeles, CA
Pfizer Inc.
Class II Terminated
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, I...
Reason: Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
D-0835-2020 February 19, 2020 New York, NY
Assurance Infusion
Class II Terminated
BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0706-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0722-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0693-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0676-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0734-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0720-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0753-2020 January 22, 2020 Houston, TX
Assurance Infusion
Class II Terminated
FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason: Lack of sterility assurance.
D-0732-2020 January 22, 2020 Houston, TX