The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1158-2018·Announced 2018-09-05

Auro Pharmacies Recalls Dexpanthenol Injectable Vials Due to Sterility Concerns

Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable due to inadequate processes and equipment 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe (Score 4), particularly when structural or process defects are involved that could lead to infection.

Plain-English summary

Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial. The product is prescription-only and was distributed nationwide in the USA. The recall involves specific lots: 180529/2 (Exp 27-Aug-18) and 180620/11 (Exp 18-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 a 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.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be discontinued and returned to the supplier or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the affected lots are provided in the source text.

The recalled product

Product
Dexpanthenol injectable, 250 mg/mL, 10 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
91

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 #: 180529/2
  • Exp 27-Aug-18 and 180620/11
  • Exp 18-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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