# FDA recall D-0700-2018

> **Premier Pharmacy Labs Inc** · Class II · drug recall initiated 2018-04-11.

## Product

Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265  Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10

## Reason for recall

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0700-2018
- **Recalling firm:** Premier Pharmacy Labs Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-11
- **Report date:** 2018-05-02
- **Termination date:** 2020-09-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0700-2018

## Citation

> AI Analytics. FDA recall D-0700-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0700-2018. Source: US FDA. Licensed CC0.

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