The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0731-2021·Announced 2021-08-25

Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance

Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.

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 for a sterile injectable drug product with potential for serious health consequences if contaminated product is administered. Lack of sterility assurance in an injectable pharmaceutical meets the Severe criterion for injectable medications with potential for harm, even absent reported hospitalizations in the source text.

Plain-English summary

Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in 1 mL single-dose vials (NDC 0703-0031-01), 5 mL multi-dose vials (NDC 0703-0043-01), and 10 mL multi-dose vials (NDC 0703-0045-01). The recall affects approximately 193,845 vials distributed nationwide, including Puerto Rico.

The reason for the recall is lack of assurance of sterility. The affected lot numbers are: 31328455B (exp. 09/2021), 31329340B (exp. 12/2021), 31329439B (exp. 01/2022), 31328347B (exp. 07/2021) for 1 mL vials; 31328321B (exp. 07/2021) for 5 mL vials; and 31328368B, 31328394B (exp. 07/2021), 31328699B (exp. 09/2021), 31328834B (exp. 10/2021), and 31329286B (exp. 12/2021) for 10 mL vials.

Healthcare providers and patients who have received this product should contact their pharmacy or healthcare provider for guidance. Patients should not stop using their medication without consulting their healthcare provider.

The recalled product

Product
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Injectable / Corticosteroid
Hazard
Affected units
193,845

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 (15)

  • Lot #: a) 31328455B
  • exp. date 09/2021
  • 31329340B
  • exp. date 12/2021
  • 31329439B
  • exp. date 01/2022
  • 31328347B
  • exp. date 07/2021 b) 31328321B
  • exp. date 07/2021
  • c) 31328368B
  • 31328394B
  • 31328699B
  • 31328834B
  • exp. date 10/2021
  • 31329286B

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 →

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