The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1160-2018·Announced 2018-09-05

Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

Auro Pharmacies, Inc. is recalling 114 vials of Methyl-Cobalamin injectable because inadequate processes and equipment failed to assure product 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Auro Pharmacies, Inc. is recalling 114 vials of Methyl-Cobalamin injectable, 1 mg/mL, packaged in 5 mL and 30 mL multiple-dose vials. The product was compounded by Central Drugs Compounding Pharmacy in La Habra, California, and distributed nationwide in the United States. The affected lot number is 180618/2, with an expiration date of September 16, 2018.

The recall was initiated due to a lack of assurance of sterility. The source text states that inadequate processes and equipment were used to assure the sterility of products intended to be sterile. This is a prescription-only medication.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, 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
114

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 #: a) 180618/2
  • Exp 16-Sep-18
  • b) 180618/2

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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