Main Street Compounding Pharmacy Recalls Acetylcystein 10% Vials
Main Street Family Pharmacy is recalling Acetylcystein 10% vials due to adverse reactions reported for a different 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 reports of adverse reactions (skin abscesses), which aligns with the rubric for Severe severity involving significant injury reports or Class II classifications with reported harm.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling Acetylcystein 10% 100mg/ml 4ml vials. The recall is associated with the firm's compounded products.
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. The source text does not specify if the Acetylcystein vials were directly involved in these specific reports, but the recall action is tied to the firm's compounding operations.
The affected units were distributed nationwide, including in 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. All codes distributed prior to and including 05/23/2013 are affected. Consumers should stop using the product and contact the pharmacy for further instructions.
The recalled product
- Product
- Acetylcystein 10% 100mg/ml 4ml, 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
- 1
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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