CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Drugs Recalls
Prescription and over-the-counter medications
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
Teva Pharmaceuticals USA
Labeling: Incorrect or Missing Package Insert
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Amerisource Health Services
CGMP Deviations: recalling drug products following an FDA inspection.
potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0427-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
EPINEPHrine added to 0.9% sodium chloride, 4 mg/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 71285-8093-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0420-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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 71285-0423-1.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.