FDA (Drugs) recall action 87298

Teva Pharmaceuticals USA recalled 15 products on 2021-03-03

The FDA (Drugs) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2021-03-03
Critical: 0
Units: 1,411,625

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–15 of 15

SevereFDA (Drugs)··2021-03-03
Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling 6,710 vials of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Metoclopramide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Metoclopramide Injection because manufacturing areas exceeded microbial acceptance levels, creating a lack of sterility assurance.
Product
METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Desmopressin Acetate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Desmopressin Acetate Injection because manufacturing areas exceeded microbial limits, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.
Product
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Vecuronium Bromide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Vecuronium Bromide for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling 15,043 vials of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Epoprostenol Sodium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Sterile Diluent for Epoprostenol Sodium Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Sterile Diluent for Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Toposar Etoposide Injection Due to Sterility Assurance Issues
Teva Pharmaceuticals is recalling Toposar (etoposide) injection vials because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Epoprostenol Sodium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state
SevereFDA (Drugs)··2021-03-03
Teva Recalls Dacarbazine Injection Due to Sterility Assurance Concerns
Teva Pharmaceuticals is recalling Dacarbazine for Injection USP because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.
Product
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.
Category
Distribution
1 state