Hydroxyprogesterone Caproate Injectable Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Hydroxyprogesterone Caproate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectables) map to a score of 4 (Severe), as Class I is required for score 5.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Hydroxyprogesterone Caproate (Sesame Oil), 250mg/mL, injectable, 5 mL glass vials. The recall is being conducted due to concerns regarding quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The affected product is a prescription injectable medication distributed in Oregon and Washington. The recall covers all lots of sterile products compounded by the pharmacy that are not expired. Specific lot numbers and discard dates are listed in the structured product information.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified 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 (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
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 #: 20140718@1/5
- discard date: 1/14/2015
- Lot #: 20140813@25
- discard date: 2/9/2015
- Lot #: 20140903@32
- discard date: 3/2/2015.
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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.
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