The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0004-2017·Announced 2016-10-12

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard

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.

See all 3 products in this recall →

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