CLASS II Drug recall · Reported 11 Dec 2013 · FDA Enforcement Report
Aminophylline 25mg/ml, Main Street Compounding Pharmacy recalled
Main Street Family Pharmacy is recalling Aminophylline 25mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, distributed nationwide in the US. The recall was initiated on 28 May 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-040-2014
- FDA event ID
- 65479
- Recalling firm
- Main Street Family Pharmacy, Newbern, TN
- Classification
- Class II
- 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
Aminophylline 25mg/ml 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 Aminophylline 25mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern recalled?
Yes. Main Street Family Pharmacy recalled Aminophylline 25mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern on 28 May 2013. The recall is Class II and its status is Terminated. Recall number D-040-2014.
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?
all codes distributed prior to and including 05/23/2013
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 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 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 |