Compounded Progesterone Oil Recalled for Non-Sterility Risk
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
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 classified this as a Class I recall, which requires a minimum severity score of 4 per the rubric. Non-sterile compounded injectable medications pose a significant risk of serious infection or harm, even though no illnesses or injuries are reported in the source text.
Plain-English summary
People's Custom Rx and Clinical Care, LLC is recalling C-Progesterone Oil 100 mg/mL (10 mL vials) due to non-sterility. The recalled product is a compounded prescription medication distributed in Mississippi and Tennessee.
Lot 11649 with a Beyond Use Date of July 7, 2021 is subject to recall. A total of 14 vials have been distributed. The firm initiated this voluntary recall on May 11, 2021, and it was classified as a Class I recall by the FDA on August 9, 2021.
Patients who have received this medication should contact their healthcare provider or pharmacy. Compounded medications that fail sterility standards may pose serious health risks if administered. The recall was terminated on August 20, 2024.
The recalled product
- Product
- C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
- Manufacturer
- People's Custom Rx and Clinical Care, LLC
- Category
- Drug — Compounded Medication
- Affected units
- 14
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 (1)
- Lot: 11649 BUD: 07/07/2021
Distribution
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