Agency classClass IIOur severity:Severe FDA (Drugs)·D-0370-2022·Announced 2022-01-19

Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance

Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.

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: This is an FDA Class II recall of an injectable pharmaceutical product. Injectable medications with sterility concerns pose a significant risk of serious infection and potential for hospitalization if sterile barriers are compromised, meeting the Severe category criteria for Class II recalls with serious injury potential.

Plain-English summary

Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 400 mg/10mL (40 mg/mL), 10 mL Multiple-Dose Vials, manufactured for Northstar Rx LLC in Memphis, TN. The recall has been issued due to lack of assurance of sterility in the recalled product.

Affected product: Methylprednisolone Acetate Injectable Suspension USP 400 mg/10mL (40 mg/mL), 10 mL Multiple-Dose Vials, Rx Only, NDC 16714-090-01, Lot #100022393 with expiration date 09/2022. Approximately 7,400 cartons were distributed.

The product was distributed to facilities in Tennessee, Mississippi, and Ohio. Healthcare providers and patients who have received this product should consult their healthcare provider regarding potential exposure. Patients should not stop taking this medication without speaking to their healthcare provider first, as abrupt discontinuation may pose health risks.

The recalled product

Product: MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Suspension
Hazard: lack-of-sterility
infection-risk
Affected units: 7,400

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 # 100022393
exp 09/2022

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · lack of sterility