Agency classClass IIOur severity:Severe FDA (Drugs)·D-0376-2021·Announced 2021-05-26

Teva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.

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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of serious injury from non-sterile injectable medication.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vials. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product is identified by Lot # 31327989B with an expiration date of 04/2021. The product was distributed nationwide. The recall involves 7,564 cartons, with each carton containing one multiple dose vial.

Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions. Consumers should not use the product and should return it to the pharmacy or contact the manufacturer for a refund.

The recalled product

Product: Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Steroid
Hazard: sterility
infection

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 # 31327989B
exp. date 04/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility