Methylprednisolone 40mg PF 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, ...

FDA Drug Recall #D-216-2014 — Class II — May 28, 2013

Recall Summary

Recall Number D-216-2014
Classification Class II — Moderate risk
Date Initiated May 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Main Street Family Pharmacy, LLC
Location Newbern, TN
Product Type Drugs
Quantity 2084 units

Product Description

Methylprednisolone 40mg PF 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

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.

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

Lot / Code Information

all codes distributed prior to and including 05/23/2013

Other Recalls from Main Street Family Pharmacy, LLC

Recall # Classification Product Date
D-248-2014 Class II Mitomycin 40mg, Main Street Compounding Pharmac... May 28, 2013
D-147-2014 Class II HCG 5000iu kit, Main Street Compounding Pharmac... May 28, 2013
D-145-2014 Class II HCG 5,000U, Main Street Compounding Pharmacy, 1... May 28, 2013
D-265-2014 Class II Sermorelin 3mg, Main Street Compounding Pharmac... May 28, 2013
D-132-2014 Class II HCG 3000IU, Main Street Compounding Pharmacy, 1... May 28, 2013

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.