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.

26–50 of 108

HighFDA (Drugs)··2023-05-31
FDA Recalls NORepinephrine Injection Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 6,414 bags of NORepinephrine injection nationwide after an FDA inspection questioned the sterility of the product. Healthcare facilities should stop using and quarantine affected lots.
Product
NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
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HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 60 Neonatal TPN Starter Bags distributed nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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 71285-0430-1.
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0 states
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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0 states
HighFDA (Drugs)··2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
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HighFDA (Drugs)··2023-05-31
FDA Recalls Compounded Injectable Solution Due to Sterility Failure
Central Admixture Pharmacy Services recalled 653 bags of compounded injectable solution nationwide following an FDA inspection that questioned the product's sterility. The solution is intended for sterile injection use.
Product
MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.
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HighFDA (Drugs)··2023-05-31
FDA Recalls Norepinephrine Injection Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,041 bags of norepinephrine injection nationwide due to FDA concerns about product sterility. Healthcare providers should immediately stop using affected lots.
Product
norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1.
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HighFDA (Drugs)··2023-05-31
FDA Recalls Microplegia Solution for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.
Product
Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
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HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bags Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0419-1.
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HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 308 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterility assurance.
Product
Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.
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HighFDA (Drugs)··2023-05-31
Vasopressin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
Product
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
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HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 476 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterile assurance.
Product
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.
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HighFDA (Drugs)··2023-05-31
FDA Recalls Phenylephrine Injectable Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 5,304 bags of phenylephrine injection nationwide after FDA inspection raised concerns about product sterility assurance.
Product
PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.
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HighFDA (Drugs)··2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.
Product
Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.
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HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags after FDA inspection questioned whether these injectable products maintain required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/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 71285-0416-1.
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HighFDA (Drugs)··2023-05-31
Vancomycin and Dextrose Injection Sterility Recall by Central Admixture
Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.
Product
vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1.
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HighFDA (Drugs)··2023-05-31
FDA Recalls Heparin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 5,207 bags of heparin injectable nationwide due to an FDA-identified sterility assurance failure. The company cannot guarantee the sterility of affected lot numbers.
Product
heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.
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HighFDA (Drugs)··2023-05-31
Neonatal TPN Starter Bag Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services recalls 558 bags of Neonatal TPN Starter Bag nationwide due to lack of sterility assurance identified during an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0405-1.
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