May 2021 FDA Recall Drug by People's Custom Rx And Clinical Care, Llc
D-0718-2021 - Non-Sterility

This Class I drug recall was voluntarily initiated by People's Custom Rx And Clinical Care, Llc on May 11, 2021 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in MS, TN and the recall is currently terminated.

Recall Number: D-0718-2021

Reason for Recall
Non-Sterility
Initiated
05-11-2021
Reported
08-18-2021
Quantity
14 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88340
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
People's Custom Rx and Clinical Care, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-20-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: 11649 BUD: 07/07/2021