Agency classClass IIOur severity:Severe FDA (Drugs)·D-0283-2021·Announced 2021-03-03

Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns

Teva Pharmaceuticals is recalling 6,710 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures in injectable products, which carry a risk of serious injury or hospitalization, are categorized as Severe (Score 4).

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 6,710 vials of MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial. The affected product is identified by Lot # 31328768B with an expiration date of 09/2021. The product was distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to a lack of assurance of sterility. According to the source text, manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery. This condition led to a lack of sterility assurance for these sterile injectable products.

Healthcare providers and patients should discontinue use of the affected vials and contact Teva Pharmaceuticals USA for further instructions or replacement. This is a prescription-only medication, and specific guidance should be obtained from medical professionals.

The recalled product

Product: MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Sterile Product
Hazard: sterility-failure
microbial-contamination
Affected units: 6,710

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 # 31328768B
exp. date 09/2021

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