D-1503-2012 Class II Terminated
FDA drug recall D-1503-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 25, 2012 and is designated Class II. 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… The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 26 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2012
- Initiation Date
- May 25, 2012
- Termination Date
- Aug 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 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 Pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Code Information
Rx #'s: 0387528 0395197 0389191 0390909 0406810 0409865 0388591 0388594 0388595 0388597 0388598 0388599 0388602 0388604 0391126 0390909 0390909 0397860 0400856 0402992 0404849 0406843
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1503-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026