CLASS II Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
All Compounded Products recalled by Med Prep Consulting
Med Prep Consulting is recalling All Compounded Products, distributed nationwide in the US. The recall was initiated on 14 Mar 2013 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-811-2013
- FDA event ID
- 64640
- Recalling firm
- Med Prep Consulting, Tinton Falls, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2013
- FDA classified
- 19 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Mold
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Mar 2013 | Recall initiated by company | |
| 19 Jul 2013 | Classified by FDA | +127 days |
| 31 Jul 2013 | 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; potential for mold contamination
Product as listed by the FDA
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Where it was distributed
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
Nationwide DelawareFloridaIllinoisIndianaMaineMichiganNew JerseyPennsylvaniaTexasVirginia
Questions about this recall
Is All Compounded Products recalled?
Yes. Med Prep Consulting recalled All Compounded Products on 14 Mar 2013. The recall is Class II and its status is Terminated. Recall number D-811-2013.
Why was it recalled?
Lack of Assurance of Sterility; potential for mold contamination
Which lots are affected?
All lots
Where was it sold?
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
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 Med Prep Consulting
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Magnesium Sulfate in Dextrose 5% for Injection recalled | Med Prep Consulting | Mold | Nationwide |