Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.

FDA recall notice · announced July 5, 2017 · Apothecary By Design

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.

Reason for recall

Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 04192017@1, Exp 09/30/2017
Quantity: 25 vials
Status: Terminated
Products in this recall event:
- Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME. (D-0924-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.