# FDA recall D-0756-2023

> **Amneal Pharmaceuticals of New York, LLC** · Class III · drug recall initiated 2023-05-08.

## 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 Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.

## Reason for recall

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

## Distribution

Nationwide in the USA and PR

## Key facts

- **Recall number:** D-0756-2023
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-08
- **Report date:** 2023-05-31
- **Termination date:** 2024-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brookhaven, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0756-2023

## Citation

> AI Analytics. FDA recall D-0756-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0756-2023. Source: US FDA. Licensed CC0.

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