Drug Recalls

Teva Pharmaceuticals USA

Class II Terminated

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC...

Reason: Lack of Assurance of Sterility

D-0731-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

Reason: Lack of Assurance of Sterility

D-0735-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01

Reason: Lack of Assurance of Sterility

D-0733-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01

Reason: Lack of Assurance of Sterility

D-0738-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1...

Reason: Lack of Assurance of Sterility

D-0739-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01

Reason: Lack of Assurance of Sterility

D-0742-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

Reason: Lack of Assurance of Sterility

D-0736-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

Reason: Lack of Assurance of Sterility

D-0730-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01

Reason: Lack of Assurance of Sterility

D-0746-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01

Reason: Lack of Assurance of Sterility

D-0744-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, P...

Reason: Lack of Assurance of Sterility

D-0732-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01

Reason: Lack of Assurance of Sterility

D-0737-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

Reason: Lack of Assurance of Sterility

D-0748-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01

Reason: Lack of Assurance of Sterility

D-0740-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA...

Reason: Lack of Assurance of Sterility

D-0743-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

Reason: Lack of Assurance of Sterility

D-0734-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91

Reason: Lack of Assurance of Sterility

D-0747-2021 August 25, 2021 Parsippany, NJ

Med Shop Total Care Inc.

Class I Terminated

HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason: Non-Sterility

D-0716-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason: Non-Sterility

D-0704-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason: Non-Sterility

D-0715-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG...

Reason: Non-Sterility

D-0717-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason: Non-Sterility

D-0705-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281...

Reason: Non-Sterility

D-0709-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason: Non-Sterility

D-0707-2021 August 18, 2021 Longview, TX

Med Shop Total Care Inc.

Class I Terminated

FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason: Non-Sterility

D-0706-2021 August 18, 2021 Longview, TX

FDA Enforcement Report