Central Admixture Pharmacy Services PHENYLephrine added to 0 Recall

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.

Lot # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/2023; 37-884749, 37-884751, Exp 05/05/2023; 37-885338, Exp 05/08/2023; 37-885756, Exp 05/09/2023; 37-886272, Exp 05/11/2023; 37-887512, Exp 05/16/2023; 37-888027, 37-888030, 37-888040, 37-888052, 37-888063, Exp 05/18/2023; 37-888314, Exp 05/21/2023; 37-890489, 37-890497, 37-890534, Exp 05/29/2023; 37-890933, Exp 05/30/2023; 37-891152, Exp 05/31/2023; 37-892985, 37-892986, 37-892995, Exp 06/07/2023; 37-893511, 37-893517, Exp 06/11/2023; 37-896481, Exp 06/21/2023; 37-897828, Exp 06/27/2023; 37-898523, Exp 06/29/2023

Nationwide in the USA.

• Compare the lot number and expiration date on your package with the codes above.
• Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
• If you have symptoms you think are related, contact your doctor. In an emergency call 911.
• Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall number

D-0733-2023

Classification

Class II

Status

Terminated

Recall initiated

Apr 28, 2023

FDA report date

May 31, 2023

Quantity

13953 bags

Recall type

Voluntary: Firm initiated

Recalling firm

Central Admixture Pharmacy Services, Inc.