Why it was 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.
Product description
Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Lot numbers, UPCs & expiration codes
all codes distributed prior to and including 05/23/2013
Where it was 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 to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-031-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2013
- FDA report date
- Dec 11, 2013
- Quantity
- 8 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Main Street Family Pharmacy, LLC
Original FDA data
Every field from FDA enforcement report D-031-2014, exactly as published.
Show all FDA fields
- City
- Newbern
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 65479
- Address
- 126 East Main Street
- Code information
- all codes distributed prior to and including 05/23/2013
- Postal code
- 38059
- Report date
- Dec 11, 2013
- Product type
- Drugs
- Recall number
- D-031-2014
- Classification
- Class II
- Recalling firm
- Main Street Family Pharmacy, LLC
- Product quantity
- 8 units
- Termination date
- Apr 22, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Distribution pattern
- 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
- Recall initiation date
- May 28, 2013
- Initial firm notification
- Telephone
- Center classification date
- Dec 3, 2013