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.

1–25 of 108

HighFDA (Drugs)··2023-05-31
Injectable Drug Recalled for Unverified Sterility After FDA Inspection
Central Admixture Pharmacy Services is recalling 1673 bags of HyperLyte CR Injection due to lack of sterility assurance. An FDA inspection raised questions about whether the product met sterility standards.
Product
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
OxyTOCIN-dextrose injectable recalled nationwide for sterility assurance concerns
Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in dextrose 5%/Lactated Ringer's solution nationwide due to lack of sterility assurance identified during FDA inspection. 7,595 bags across multiple lot numbers are affected.
Product
oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.
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.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
FDA Recalls Neonatal TPN Starter Bags for Sterility Concerns
Central Admixture Pharmacy Services recalls 747 bags of Neonatal TPN Starter Bags due to FDA sterility concerns. Products were distributed nationwide across the USA.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0422-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Induction 4:1 High Potassium) due to lack of sterility assurance following an FDA inspection. The recall affects 84 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Vancomycin Sodium Chloride Injection Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 11,338 bags of vancomycin sodium chloride injection nationwide due to FDA concerns about product sterility following an inspection.
Product
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bags Recalled for Sterility Assurance Issue
Central Admixture Pharmacy Services recalls 138 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned the products' sterility assurance. Affected lots expire between April and May 2023.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
IV Potassium Phosphate Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.
Product
potassium phosphate 15 mmole 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 71285-6060-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.
Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.
Product
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bags Recalled for Unassured Sterility
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Neonatal TPN Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0428-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.
Product
Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1.
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
FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance
The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.
Product
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Heparin Injection Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.
Product
heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
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
Cardioplegia Solution Recalled Nationwide for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.
Product
Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 167 bags of neonatal TPN Starter Bag due to FDA concerns about product sterility identified during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.
Product
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recall Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of assurance of sterility. An FDA inspection raised concerns about whether the 329 bags were properly sterilized.
Product
Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bag Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0418-1.
Category
Distribution
0 states
HighFDA (Drugs)··2023-05-31
Potassium Acetate Injection Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.
Product
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
Category
Distribution
0 states