Main Street Compounding Pharmacy Recalls Wydase 5ml Due to Sterility Concerns
Main Street Family Pharmacy is recalling 50 units of Wydase 5ml because the product lacks assurance of sterility. The recall covers units distributed nationwide prior to and including May 23, 2013.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in a drug product is a significant safety hazard that aligns with the Severe classification for Class II recalls where risk is substantial.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 50 units of Wydase 5ml. The recall was initiated because the product lacks assurance of sterility. The affected units were 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 applies to all codes distributed prior to and including May 23, 2013. The product was manufactured by Main Street Family Pharmacy, LLC, located at 126 East Main Street, Newbern, TN 38059.
Consumers who have this product should stop using it and contact the recalling firm at 888-658-6200 for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 50
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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