Agency classClass IIOur severity:Severe FDA (Drugs)·D-1512-2016·Announced 2016-09-28

The Apothecary Recalls Prostaglandin and Other Medications Due to Sterility Concerns

The Apothecary is recalling specific lots of Prostaglandin and other medications due to a lack of assurance of sterility and unsubstantiated validation of beyond-use dating.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in injectable medications which carry significant risk.

Plain-English summary

The Apothecary, a compounding pharmacy located in Sartell, Minnesota, is recalling specific lots of Prostaglandin 200 mcg/0.1 mL, as well as medications containing Calcium Gluconate, Papaverine, and Phentolamine. The recall is being conducted due to a lack of assurance of sterility and unsubstantiated validation of beyond-use dating for these products.

The affected products are prescription-only medications distributed in Minnesota. The recall includes all unexpired lots of the specified medications. Specific lot numbers identified in the recall include 06201604@15, 19201602@3, and 06201604@8.

Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Manufacturer: W & C dba The Apothecary
Category: Drug — Compounded Medication
Hazard: sterility
infection

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 (3)

LOT #: 06201604@15
19201602@3
06201604@8

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by W & C dba The Apothecary 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 5 products in this recall →

Same manufacturer · W & C dba The Apothecary

See all →

Severe
The Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Concerns
FDA (Drugs) · 2016-09-28
Severe
The Apothecary Recalls Sterile Injection Medications Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-09-28
Severe
Calcium Gluconate Syringes Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-09-28
Severe
The Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
FDA (Drugs) · 2016-09-28

Same hazard · sterility