FDA Recall D-0718-2021
People's Custom Rx and Clinical Care, LLC · Memphis, TN
Class I — life-threatening Terminated 1197 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Non-Sterility
Recall record
- Recall number
D-0718-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- MS, TN
- Recall initiated
- 2021-05-11
- Classified by FDA Center
- 2021-08-09
- FDA published
- 2021-08-18
- Terminated
- 2024-08-20
- Recalling firm
- People's Custom Rx and Clinical Care, LLC
- Firm location
- Memphis, TN