Drug recall
17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
FDA recall event 65479 · Class I, Class II · Main Street Family Pharmacy, LLC
Key facts
| Event ID | 65479 |
|---|---|
| Recall numbers | D-024-2014, D-025-2014, D-026-2014, D-027-2014, D-028-2014, D-029-2014, D-030-2014, D-031-2014, D-032-2014, D-033-2014, D-034-2014, D-035-2014 and 258 more |
| Recalling firm | Main Street Family Pharmacy, LLC |
| Product type | Drugs |
| Products | 17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200, Acetylcystein 10% 100mg/ml 4ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200, Acetylcystein 10% 120ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200, Acetylcystein 20% 90ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200, Adenosine 35 mg/ml, 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 and 262 more |
| Classification | Class I, Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | May 28, 2013 |
| Report date | Dec 11, 2013 |
| Termination date | Apr 22, 2014 |
| City | Newbern |
| State | TN |
| Country | United States |
| FEI number | 3010199183 |
At a glance
- 100–999 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: