Category
Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-10-11FDA-DrugDr. Berne's Whole Health ProductsClass IIDr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.
CGMP Deviations
- 2023-10-11FDA-DrugDr. Berne's Whole Health ProductsClass IIDr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001036
CGMP Deviations
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIHYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIHYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIHYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIHYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIHYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIHYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIsuccinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IImidazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIfentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIrocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIPHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIPHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIPHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Lack of assurance of sterility:
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