D-1022-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 13, 2019
- Termination Date
- January 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1575 syringes
Product Description
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lots: 10/18/18 1430 87661S Exp. 3/17/2019; 10/29/18 1805 87661S Exp. 3/28/2019