Main Street Family Pharmacy Recalls Compounded Lidocaine and Phenylephrine
Main Street Family Pharmacy is recalling Lidocaine 4%/Phenylephrine 1% 5 due to adverse reaction reports linked to a related compounded product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving significant injury reports or Class II classifications with hospitalization/injury potential.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling Lidocaine 4%/Phenylephrine 1% 5. The recall involves 30 units distributed nationwide to specific states including 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. The recall covers all codes distributed prior to and including 05/23/2013.
The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials, a different product from the one listed in the recall title but associated with the same firm.
Consumers who have purchased or possess the recalled Lidocaine 4%/Phenylephrine 1% 5 should stop using the product and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions.
The recalled product
- Product
- Lidocaine 4%/Phenylephrine 1% 5, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Medication
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes distributed prior to and including 05/23/2013
Distribution
Part of a larger recall action
This product is one of 299 recalled by Main Street Family Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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