The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0271-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Methylcobalamin Injections for Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin injections due to a lack of assurance of sterility. The affected vials were distributed nationwide.

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, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in injectable drugs) corresponds to a severity score of 4 (Severe), as it is not Class I but involves significant risk.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Methylcobalamin 10,000mcg/mL MDV Injection, 30ml glass vials. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product consists of 135 vials of S-Methylcobalamin 10,000mcg/mL MDV Injection. The specific lot numbers and expiration dates are listed in the recall documentation. The product was distributed nationwide in the USA.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx
Manufacturer
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category
Drug — Injectable
Hazard

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 (20)

  • Lot #: S05162019DH@12
  • Exp 8/16/19
  • S05282019DT@06
  • Exp 8/28/19
  • S05302019DT@05
  • Exp 8/30/19
  • S06182019DT@03
  • Exp 9/18/19
  • S07102019dt@05
  • Exp 10/10/19
  • S07162019DT@08
  • Exp 10/16/19
  • S07242019DH@02
  • Exp 10/24/19
  • S07252019DH@08
  • Exp 10/25/19
  • S06242019DH@01
  • Exp 9/24/19
  • S07032019DT@10
  • EXP 10/03/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 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 100 products in this recall →

Related recalls

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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Same hazard · sterility

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