CLASS I Drug recall · Reported 11 Dec 2013 · FDA Enforcement Report
Methylprednisolone 80mg/ml (PF) recalled by Main Street Family Pharmacy
Main Street Family Pharmacy is recalling Methylprednisolone 80mg/ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class I.
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-220-2014
- FDA event ID
- 65479
- Recalling firm
- Main Street Family Pharmacy, Newbern, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 May 2013
- FDA classified
- 3 Dec 2013
- Reported
- 11 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Compounded Drugs
Timeline
| 28 May 2013 | Recall initiated by company | |
| 3 Dec 2013 | Classified by FDA | +189 days |
| 11 Dec 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Product as listed by the FDA
Methylprednisolone 80mg/ml (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Where it was distributed
nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMinnesotaMissouriMississippi
Questions about this recall
Is Methylprednisolone 80mg/ml (PF), Main Street Compounding Pharmacy, 126 East Main Street recalled?
Yes. Main Street Family Pharmacy recalled Methylprednisolone 80mg/ml (PF), Main Street Compounding Pharmacy, 126 East Main Street on 28 May 2013. The recall is Class I and its status is Terminated. Recall number D-220-2014.
Why was it recalled?
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Which lots are affected?
Lot# 012813dan, 011413dan, 010913dan
Where was it sold?
nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Main Street Family Pharmacy
All 299| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mitomycin 40mg, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |
| Drug | CLASS II | HCG 5000iu kit, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |
| Drug | CLASS II | HCG 5,000U, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |
| Drug | CLASS II | Sermorelin 3mg, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |
| Drug | CLASS II | HCG 3000IU, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |