The Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection from non-sterile injectable medication.
Plain-English summary
The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials. The recall is due to a lack of assurance of sterility, as the medication was sterilized with a filter that has been recalled.
The affected product is a prescription medication intended for intramuscular injection. The recall involves a total volume of 247.5 mL. The specific lots affected are identified by the codes 07252016@22 with a best-use date of 09/22/2016, and 08102016@28 with a best-use date of 10/08/2016.
The product was distributed in Oklahoma. Patients and healthcare providers who have this medication should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Injectable Medication
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 (2)
- 07252016@22 BUD 09/22/2016
- 08102016@28 BUD 10/08/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by The Apothecary Shoppe 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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