Agency classClass IIOur severity:Severe FDA (Drugs)·D-0742-2021·Announced 2021-08-25

Teva Alprostadil Injection Recalled for Lack of Sterility Assurance

Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

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: This is an FDA Class II recall of a sterile injectable product. Loss of sterility assurance in injectable pharmaceuticals poses a significant risk of serious infection and potential hospitalization, meeting the criteria for Severe classification even without reported illness data.

Plain-English summary

Teva Pharmaceuticals USA is recalling Alprostadil Injection USP, 500 mg/mL, 1 mL single-dose vials (NDC 0703-1501-01 and NDC 0703-1501-02) due to lack of assurance of sterility. The recalled lot is #31329295B with an expiration date of 01/2022, comprising 2,199 vials.

The product was distributed nationwide, including Puerto Rico. Alprostadil Injection is a prescription medication, and sterility assurance is critical for injectable products to prevent contamination and infection.

Patients currently using this product should consult their healthcare provider about whether they have a vial from the recalled lot and what steps to take. Healthcare providers and distributors should identify and quarantine any remaining product from lot #31329295B.

The recalled product

Product: 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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable
Hazard: lack-of-sterility
contamination-risk
Affected units: 2,199

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 #: 31329295B
exp date. 01/2022

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