The Recall Desk
SevereFDA (Drugs)·D-0231-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls S-Hydroxyprogesterone Caproate Injections

Red Mountain Compounding Pharmacy is recalling S-Hydroxyprogesterone Caproate injections due to a lack of 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, which corresponds to a Severe severity score under the rubric for drug recalls.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Hydroxyprogesterone Caproate 250mg/mL in Sesame Oil Injection, 5ml glass vials. The recall is being conducted because there is a lack of assurance of sterility for the product.

The affected product is identified by Lot Number S06192019DT@09 and has an expiration date of 9/19/19. The product was distributed nationwide in the United States.

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

The recalled product

Product
S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx
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 (2)

  • Lot #: S06192019DT@09
  • Exp 9/19/19

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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