Agency classClass IIOur severity:Severe FDA (Drugs)·D-0266-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-HCG/B12A Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-HCG/B12A injection vials due to a lack of assurance of sterility. The recall affects 11 vials 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the snippet, the agency classification of Class II for a sterile injection product aligns with the Severe criteria for significant risk.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-HCG/B12A 1000U/5MG/ML MDV INJ. The product is packaged in 5ml and 10ml glass vials and is available by prescription only. The recall involves 11 vials in total.

The recall was initiated due to a lack of assurance of sterility. The affected lots include S06112019DH@10, S06142019DH@03, S06252019DH@14, and S07222019DH@02, with expiration dates ranging from August 11, 2019, to September 22, 2019.

The product was distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots.

The recalled product

Product: S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility

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 (9)

Lot #: a) S06112019DH@10
Exp 8/11/19
b) S06112019DH@10
S06142019DH@03
Exp 8/14/19
S06252019DH@14
Exp 8/25/19
S07222019DH@02
Exp 9/22/19

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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