Calcium Gluconate Syringes Recalled Due to Sterility Assurance Concerns
The Apothecary is recalling Calcium Gluconate syringes 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 involves a lack of sterility assurance, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
The Apothecary, a compounding pharmacy in Sartell, Minnesota, is recalling Calcium Gluconate 2.5% 20 mL plastic syringes. The recall includes all unexpired lots of medications containing Calcium Gluconate, Papaverine, Phentolamine, and/or Prostaglandin.
The recall was initiated due to a lack of assurance of sterility and unsubstantiated validation of beyond use dating. The specific lot number identified is 12201604@22, with a total quantity of 840 mL distributed in Minnesota.
Patients who have received these medications should contact their healthcare provider for further instructions. The FDA classifies this as a Class II recall.
The recalled product
- Product
- Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, 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
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)
- LOT #: 12201604@22
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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