Agency classClass IIIOur severity:Low FDA (Drugs)·D-0756-2023·Announced 2023-05-31

Methylprednisolone Acetate Injectable Suspension recalled for NDC carton labeling error

Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a typographical error in the NDC number on secondary packaging (cartons only). The medication itself and the vial labeling are unaffected. No illnesses, injuries, or adverse events have been reported. Per the severity rubric, documentation issues and packaging-only problems score as Low (1).

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL for intramuscular, intrasynovial, and soft tissue injection in 1 mL single-dose vials. The recall is due to a typographical error in the NDC number printed on the product's secondary packaging (folding cartons). The product was manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed nationwide throughout the United States and Puerto Rico.

The affected product displays an incorrect NDC number (70121-1573-1) on the carton labeling, when the correct NDC number is 70121-1574-1. This error appears only on the secondary packaging and does not affect the medication vial itself or its contents. Approximately 69,239 vials are involved in the recall under lot numbers AP220481 (expiration 09/2024) and AP220536A (expiration 10/2024).

Patients and healthcare providers should verify the correct NDC number directly on the vial if they have questions. No adverse events or safety issues have been reported in connection with this labeling error.

The recalled product

Product: Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal…
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Injectable Corticosteroid
Hazard: mis-labeling
Affected units: 69,239

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 (4)

Lot Numbers: AP220481
Exp 09/2024
AP220536A
Exp 10/2024

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Amneal Pharmaceuticals of New York, LLC

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