# FDA recall D-1514-2022

> **Pine Pharmaceuticals, LLC** · Class II · drug recall initiated 2022-07-27.

## Product

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY  14150.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Product was distributed to direct accounts in AL, CA, NC and NY

## Key facts

- **Recall number:** D-1514-2022
- **Recalling firm:** Pine Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-27
- **Report date:** 2022-09-21
- **Termination date:** 2022-10-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1514-2022

## Citation

> AI Analytics. FDA recall D-1514-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-1514-2022. Source: US FDA. Licensed CC0.

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