FDA (Drugs) recall action 92253

Central Admixture Pharmacy Services, Inc. recalled 108 products on 2023-05-31

The FDA (Drugs) publishes a recall like this one as 108 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 108 pages.

Products: 108
Announced: 2023-05-31
Critical: 0
Units: 440,821

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

101–108 of 108

HighFDA (Drugs)··2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to FDA concerns about sterility assurance. The recall affects 52 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Tromethamine Injectable Syringes Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 225 syringes of tromethamine 0.3 Molar nationwide due to lack of sterility assurance identified during an FDA inspection. No illnesses have been reported.
Product
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
FDA Recalls Neonatal Parenteral Nutrition Bags for Sterility Concerns
Central Admixture Pharmacy Services recalled 328 neonatal parenteral nutrition bags nationwide due to FDA concerns about product sterility after an inspection.
Product
Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
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Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled Nationwide Due to Unverified Sterility
Central Admixture Pharmacy Services is recalling 79 bags of Cardioplegia Solution nationwide because an FDA inspection found that the sterility of the product could not be assured.
Product
Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardiac Perfusion Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.
Product
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Phenylephrine Injectable Solution Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 13,953 bags of phenylephrine injectable solution nationwide due to FDA concerns about sterility assurance identified during inspection.
Product
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.
Category
Distribution
0 states