CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Hydrochloric Acid Injection 2mg/ML Injectable (2 Different Products) recalled
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Hydrochloric Acid Injection 2mg/ML Injectable (2 Different Products), distributed nationwide in the US. The recall was initiated on 25 May 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1538-2012
- FDA event ID
- 62416
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 May 2012
- FDA classified
- 10 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 May 2012 | Recall initiated by company | |
| 10 Aug 2012 | Classified by FDA | +77 days |
| 22 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
Where it was distributed
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Questions about this recall
Is Hydrochloric Acid Injection 2mg/ML Injectable (2 Different Products) recalled?
Yes. Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled Hydrochloric Acid Injection 2mg/ML Injectable (2 Different Products) on 25 May 2012. The recall is Class II and its status is Terminated. Recall number D-1538-2012.
Why was it recalled?
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.
Which lots are affected?
Rx #'s: 0389733 0398961 0398282
Where was it sold?
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Franck's Lab Inc., d.b.a. Franck's Compounding Lab
All 198Other Hydrochloric acid recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrochloric Acid Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |