The Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
The Apothecary is recalling unexpired lots of Papaverine, Phentolamine, Calcium Gluconate, and Prostaglandin medications due to unsubstantiated validation of beyond use dating and lack of 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, and the rubric specifies that FDA Class II recalls with potential for serious injury (such as sterility issues in injectable medications) are rated as Severe.
Plain-English summary
The Apothecary, a compounding pharmacy located in Sartell, Minnesota, is recalling specific unexpired lots of medications containing Calcium Gluconate, Papaverine, Phentolamine, and/or Prostaglandin. The recall is being conducted because of a lack of assurance of sterility resulting from unsubstantiated validation of beyond use dating.
The affected products include Papaverine 30 mg / Phentolamine 1 mg / mL in 5 mL glass vials. The recall covers lots 06201604@15, 19201602@3, and 06201604@8. The distribution was limited to Minnesota.
Consumers and healthcare providers should stop using the affected medications and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 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 Injectable
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 →Related recalls
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