D-0924-2017 Class II Terminated
FDA drug recall D-0924-2017 was initiated by Apothecary By Design on June 5, 2017 and is designated Class II. 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. The recall status is terminated (terminated October 6, 2017). Affected quantity: 25 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 5, 2017
- Initiation Date
- June 5, 2017
- Termination Date
- October 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 vials
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 04192017@1, Exp 09/30/2017