Agency classClass IIOur severity:Severe FDA (Drugs)·D-0743-2021·Announced 2021-08-25

Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns

Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials 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: The FDA classified this as a Class II recall. Lack of sterility assurance in an injectable pharmaceutical product poses a significant risk of serious infection or injury if the product is used, meeting the Severe (Class II) criterion in the rubric.

Plain-English summary

Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, distributed nationwide and in Puerto Rico. The recall applies to two product configurations: 1 mL single-dose vials (NDC 0703-0051-01) and 5 mL multi-dose vials (NDC 0703-0063-01). A total of 50,713 vials are affected.

The recall is due to lack of assurance of sterility. Affected lot numbers are: for single-dose vials, lot #31329363B (expiration 01/2022) and lot #31329484B (expiration 03/2022); for multi-dose vials, lot #31328367B and lot #31328431B (expiration 07/2021) and lot #31329014B (expiration 11/2021).

Consumers and healthcare providers who have received this product should discontinue use immediately. Contact Teva Pharmaceuticals USA at North Wales, PA 19454, or consult with a healthcare provider regarding appropriate action. The product is prescription-only.

The recalled product

Product: Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable / Corticosteroid
Hazard: sterility-assurance
contamination-risk
Affected units: 50,713

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 (8)

Lot #: a) 31329363B
exp. date 01/2022
31329484B
exp. date 03/2022 b) 31328367B
31328431B
exp. date 07/2021
31329014B
exp. date 11/2021

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

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Same hazard · sterility assurance