Agency classClass IIOur severity:Severe FDA (Drugs)·D-0226-2020·Announced 2019-11-13

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

Red Mountain Compounding Pharmacy is recalling 81 vials of S-HCG 1200U/ML injection solution because the product lacks assurance of 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, 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 81 vials of S-HCG 1200U/ML MDV INJ SOLN. The product is packaged in 5 mL, 10 mL, and 30 mL glass vials. The recall is being conducted because the product lacks assurance of sterility.

The affected products were distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between August and October 2019.

Consumers who have purchased or received these specific vials should stop using them and contact their healthcare provider or the recalling pharmacy for instructions on return or disposal.

The recalled product

Product: S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Solution
Hazard: lack-of-sterility
infection-risk
Affected units: 81

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 #:a) S07292019DH@01
Exp 9/29/19
S07232019DH@06
Exp 9/23/19
S06302019DH@05
Exp 8/30/19 b) S06112019DH@01
Exp 8/11/19
S06112019DH@11
S06142019DH@02
Exp 8/14/19
S06162019DH@01
8/16/19
S06182019DH@34
Exp 8/18/19
S06242019DH@16
Exp 8/24/19
Exp 8/30/19
S07102019DT@16
Exp 9/10/19
S07162019DH@02

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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