Key Takeaway

B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 by Main Street Family Pharmacy, LLC was recalled on May 28, 2013. The hazard: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolo...

FDA Drug Class II Terminated

B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Recalled: May 28, 2013 ~10 units units affected D-047-2014

Description

B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Hazard / Reason

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.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Drugs

Company Information

Main Street Family Pharmacy, LLC

Newbern, TN, United States

View all 299 recalls by Main Street Family Pharmacy, LLC →

Distribution

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

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.