The Recall Desk
SevereFDA (Drugs)·D-1097-2020·Announced 2020-04-15

Innovative Compounding Pharmacy Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns

Innovative Compounding Pharmacy is recalling Hydroxyprogesterone Caproate injections because the FDA cannot ensure the product is sterile. Patients in California, Maine, and Texas should stop using the medication.

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 FDA classifies this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4), as they are not explicitly Class I but involve significant risk.

Plain-English summary

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling specific lots of Hydroxyprogesterone Caproate (BUD) 350mg/ml, 4 mL, Injectable. The recall was initiated because the U.S. Food and Drug Administration (FDA) has determined there is a lack of assurance of sterility for the affected product.

The recall covers two specific lots: Lot # 02212020@2, which expires after 04-21-2020, and Lot # 02262020@52, which expires after 04-26-2020. The product was distributed to patients in California, Maine, and Texas.

Patients who have received this medication should stop using it and contact their healthcare provider for further instructions. The FDA classifies 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
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Manufacturer
Innovative Intrathecal Solutions, Inc. dba Innovative 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 (3)

  • Lot #: 02212020@2
  • Expires after 04-21-2020
  • Lot #: 02262020@52 Expires after 04-26-2020

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative 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 5 products in this recall →

Related recalls

Same manufacturer · Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

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Same hazard · sterility

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