Agency classClass IIOur severity:Severe FDA (Drugs)·D-0284-2021·Announced 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.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk pathogens (like sterility failures in injectables) are typically scored as Severe (4), especially when the defect is structural or fundamental to the product's safety profile (sterility).

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 15,043 vials of MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial. The product is identified by Lot # 31327738B with an expiration date of 03/2021. The recall is due to a lack of assurance of sterility, as manufacturing areas for the product exceeded acceptance levels for microbial recovery.

The affected product was distributed nationwide in the USA and Puerto Rico. This is a prescription-only medication (Rx only) manufactured by Teva Pharmaceuticals USA, Inc. in North Wales, PA.

Healthcare providers and patients should discontinue use of the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Sterile Product
Hazard: sterility-failure
microbial-contamination
Affected units: 15,043

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 # 31327738B
exp. date 03/2021

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 15 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 15 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility failure