# FDA recall D-0261-2021

> **Apotex Corp.** · Class I · drug recall initiated 2021-02-02.

## Product

Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326   NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)

## Reason for recall

Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0261-2021
- **Recalling firm:** Apotex Corp.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-02-02
- **Report date:** 2021-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2021

## Citation

> AI Analytics. FDA recall D-0261-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0261-2021. Source: US FDA. Licensed CC0.

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