The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1157-2018·Announced 2018-09-05

Auro Pharmacies Recalls Calcium Gluconate Injectable Due to Sterility Concerns

Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.

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 sterile injectable product with inadequate sterility assurance, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

Auro Pharmacies, Inc. is recalling 167 vials of Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only. The product was manufactured by Central Drugs Compounding Pharmacy, located at 520 W. La Habra Blvd, La Habra, CA 90631. The specific lot number is 180626/10, with an expiration date of 24-Sep-18.

The recall was initiated due to a lack of assurance of sterility. The source text states that there were inadequate processes and equipment to assure the sterility of products intended to be sterile. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should not be used and should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Manufacturer
Auro Pharmacies, Inc.
Category
Drug — Injectable
Hazard
Affected units
167

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)

  • Lot #: 180626/10
  • Exp 24-Sep-18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Auro Pharmacies, Inc. 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 12 products in this recall →

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