The Recall Desk
SevereFDA (Drugs)·D-0273-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Methylcobalamin Injections Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin 5,000mcg/mL injections because the product lacks assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Methylcobalamin 5,000mcg/mL MDV Injection, 30 mL glass vials. The recall is due to a lack of assurance of sterility in the product.

The affected product is a prescription-only medication distributed nationwide in the USA. The recall involves 28 vials of 30 mL each. Specific lot numbers and expiration dates are listed in the official recall notice.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX

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 (6)

  • Lot #: S07022019DT@09
  • Exp 10/2/19
  • S05082019DT@08
  • Exp 8/8/19
  • S06042019DT@07
  • Exp 9/4/19

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 →

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

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