The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1167-2018·Announced 2018-09-05

Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

Auro Pharmacies is recalling 74 vials of Methyl-Cobalamin injectable because the manufacturer could not assure the sterility of the product.

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 typically scored as Severe (4), especially when specific injury reports are not provided but the risk is significant.

Plain-English summary

Auro Pharmacies, Inc. is recalling 74 vials of Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial. The product was compounded by Central Drugs Compounding Pharmacy in La Habra, California, and distributed nationwide in the USA. The specific lot number is 180620/2, with an expiration date of 18-Sep-18.

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

Consumers and healthcare providers should stop using the affected product and contact Auro Pharmacies, Inc. for further instructions or a refund. The product is prescription-only, so patients should consult their healthcare provider regarding alternative treatments.

The recalled product

Product
Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple 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
74

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 #: 180620/2
  • 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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