Home / Recalls / Central Admixture Pharmacy Services, Inc. / D-0667-2023

D-0667-2023 Class II Terminated

Recalled by Central Admixture Pharmacy Services, Inc. — Allentown, PA

Recall Details

Product Type
Drugs
Report Date
May 31, 2023
Initiation Date
April 28, 2023
Termination Date
June 22, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
476 bags

Product Description

Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA.

Code Information

Lot # 37-894300, Exp 04/29/2023; 37-896114, Exp 05/06/2023; 37-896417, Exp 05/07/2023; 37-897388, Exp 05/12/2023; 37-898798, Exp 05/18/2023; 37-899618, Exp 05/20/2023

Other recalls by Central Admixture Pharmacy Services, Inc.

  • D-0272-2025 Class I — PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only (February 20, 2025)
  • D-0007-2024 Class II — PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syri (September 21, 2023)
  • D-0009-2024 Class II — fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx onl (September 21, 2023)
  • D-0016-2024 Class II — fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volu (September 21, 2023)
  • D-0020-2024 Class II — fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS I (September 21, 2023)
  • D-0013-2024 Class II — fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx (September 21, 2023)
  • D-0028-2024 Class II — HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, (September 21, 2023)
  • D-0018-2024 Class II — midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Centra (September 21, 2023)
  • D-0027-2024 Class II — HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, R (September 21, 2023)
  • D-0025-2024 Class II — fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixtur (September 21, 2023)