Agency classClass IIOur severity:Severe FDA (Drugs)·D-0281-2021·Announced 2021-03-03

Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns

Teva Pharmaceuticals is recalling specific lots 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 and involves a lack of sterility assurance in injectable products, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 5,378 vials of MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vials (NDC 0703-0051-01). The affected lots are # 31327909B (exp. 04/2021) and # 31328352B (exp. 07/2021). The product is packaged in 25X1ML vials per tray (NDC 0703-0051-04) and is available by prescription only.

The recall was initiated because manufacturing areas for these products exceeded acceptance levels for microbial recovery. This condition led to a lack of sterility assurance for these sterile injectable products. The FDA has classified this recall as Class II.

The product was distributed nationwide in the USA and Puerto Rico. Healthcare providers and patients should check their inventory and discontinue use of the affected lots. Patients should consult their healthcare provider for alternative treatment options if they have received this medication.

The recalled product

Product: MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Sterile Product
Hazard: sterility-failure
infection-risk
Affected units: 5,378

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 (3)

Lot # 31327909B
exp. date 04/2021 Lot # 31328352B
exp. date 07/2021

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