Multi-event February 2021 FDA Recall Metoclopramide by Teva Pharmaceuticals Usa

This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on February 10, 2021 for the product Metoclopramide. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

Recall Number: D-0280-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
12,609 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.

Batch or Lot Expiration Information

Lot# 31326456B, exp. date 02/28/2021

Recall Number: D-0272-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
2,577 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# 31326669B, exp. date 03/2021

Recall Number: D-0284-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
15,043 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.

Batch or Lot Expiration Information

Lot# 31327738B, exp. date 03/2021

Recall Number: D-0278-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
4,806 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.

Batch or Lot Expiration Information

Lot# 31327600B, exp. date 08/2022

Recall Number: D-0274-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
12,629 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.

Batch or Lot Expiration Information

Lot# 31327537B, exp. date 09/2021

Recall Number: D-0273-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
26,373 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# 31326845B, exp. date 03/2021
Lot# 31327844B, exp. date 09/2021

Recall Number: D-0275-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
5,086 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# 31327742B, exp. date 02/2021
Lot# 31328408B, exp. date 07/2021

Recall Number: D-0279-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
33,6697 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# 31325712B, exp. date 12/2021 31326320B, exp. date 02/2022 31326457B, exp. date 02/2022 31327880B, exp. date 10/2022

Recall Number: D-0281-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
5,378 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# 31327909B, exp. date 04/2021
Lot# 31328352B, exp. date 07/2021

Recall Number: D-0282-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.

Batch or Lot Expiration Information

Lot# 31327725B, exp. date 02/2021
Lot# 31327906B, exp. date 03/2021

Recall Number: D-0285-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
705,745 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.

Batch or Lot Expiration Information

Lot# a) 31324653B, exp. date 03/2021; 31326066B, exp. date 11/2021; 31326428B, exp. date 02/2022; 31327949B, exp. date 10/2022; 31327995B, exp. date 10/2022; 31328031B, exp. date 11/2022; 31328217B, exp. date 12/2022; 31328325B, exp. date 12/2022; 31328425B, exp. date 07/2021
Lot# b) 31324480B, exp. date 02/2021
Lot# 31327396B, exp. date 08/2022

Recall Number: D-0276-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
248,565 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.

Batch or Lot Expiration Information

Lot# 31326364B, exp. date 01/2022 31327120B, exp. date 05/2022 31327963B, exp. date 10/2022

Recall Number: D-0283-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
6,710 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.

Batch or Lot Expiration Information

Lot# 31328768B, exp. date 09/2021

Recall Number: D-0271-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
50 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# 31326582B, exp. date 02/2022
Lot# 31326964B, exp. date 04/2022

Recall Number: D-0277-2021

Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
02-10-2021
Reported
03-03-2021
Quantity
29,357 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Teva Pharmaceuticals USA
Product was distributed nationwide in the USA and Puerto Rico.
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.

Batch or Lot Expiration Information

Lot# 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021

Affected Packages Involved in this Recall