Recalls / Class II
Class IID-152-2014
Product
HCG Nasal Spray, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Affected lot / code info
- all codes distributed prior to and including 05/23/2013
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.
Recalling firm
- Firm
- Main Street Family Pharmacy, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 126 East Main Street, N/A, Newbern, Tennessee 38059
Distribution
- Quantity
- 43 units
- 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
Timeline
- Recall initiated
- 2013-05-28
- FDA classified
- 2013-12-03
- Posted by FDA
- 2013-12-11
- Terminated
- 2014-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-152-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.