# FDA recall D-1452-2012

> **Franck's Lab Inc., d.b.a. Franck's Compounding Lab** · Class II · drug recall initiated 2012-05-25.

## Product

ALPROSTADIL  10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL  15MCG/ML INJECTABLE 5 ML; ALPROSTADIL  20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL  24MCG/ML INJECTABLE 6 ML; ALPROSTADIL  25MCG/ML INJECTABLE 10 ML; ALPROSTADIL  30MCG/ML INJECTABLE 10 ML; ALPROSTADIL  35MCG/ML INJECTABLE 10 ML; ALPROSTADIL  40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL  50MCG/ML INJECTABLE	10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL  60MCG/ML INJECTABLE	20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE  10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS)

## Reason for recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

## Distribution

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

## Key facts

- **Recall number:** D-1452-2012
- **Recalling firm:** Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-25
- **Report date:** 2012-08-22
- **Termination date:** 2014-08-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1452-2012

## Citation

> AI Analytics. FDA recall D-1452-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1452-2012. Source: US FDA. Licensed CC0.

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