Agency classClass IIOur severity:Severe FDA (Drugs)·D-0738-2021·Announced 2021-08-25

Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance

Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class II recall. The hazard—lack of assurance of sterility in an injectable pharmaceutical product—poses a significant risk of serious adverse health outcomes if administered, particularly given that epoprostenol is used to treat serious pulmonary conditions. Although no reported illnesses or hospitalizations are stated in the source, the potential harm from non-sterile injectable medication meets the Severe criteria for Class II recalls.

Plain-English summary

Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials (NDC 0703-1995-01) due to lack of assurance of sterility.

The recalled lot is #31329113B with an expiration date of 05/2022. Approximately 12,698 vials were distributed nationwide, including Puerto Rico.

Epoprostenol Sodium for Injection is a prescription medication. Patients currently using this product should consult their healthcare provider or pharmacist before discontinuing use and to discuss alternative treatment options. Healthcare providers should also review their records to identify potentially affected patients.

The recalled product

Product: 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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Pharmaceutical
Hazard: lack-of-sterility
injectable-contamination
Affected units: 12,698

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 31329113B
exp. date 05/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

See all →

Moderate
Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
Low
Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
Moderate
Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
Low
Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
Moderate
Brinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26

Same hazard · lack of sterility