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Showing 1161–1180 of 14370 results

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Oxybutynin Chloride 10 mg (Zydus) – Dissolution Failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDASep 21, 2023Nationwide• Zydus Pharmaceuticals (USA) Inc

Fentanyl/Bupivacaine 2 mcg/0.0625% Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 1250 mcg/25 mL (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 10 mcg/1 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Hydromorphone 0.5 mg/5 mL Dextrose (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Midazolam 50 mg/50 mL Dextrose (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Hydromorphone 10 mg/50 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Pina Colada Kratom Seltzer (Kula Brands) – Allergens and Additive (2023)

Undeclared Allergen

Undeclared Allergens: Milk and Tree Nut (Coconut) and Unapproved Food Additive: Kratom

Class IHigh

FDASep 21, 2023Nationwide• Kula Brands LLC

Phenylephrine 800 mcg/10 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Ketamine 50 mg/5 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl Syringe (CAPS) – sterility concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Hydromorphone 6 mg/30 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 100 mcg/10 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Betaxolol Tablets (KVK-Tech) – Foreign Tablet Risk (2023)

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

Class IHigh

FDASep 20, 2023Nationwide• KVK-Tech, Inc.

Eligard Injection (Tolmar) – Superpotent Drug (2023)

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Class IIILow

FDASep 12, 2023Nationwide• Tolmar, Inc.

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Class IHigh

FDASep 8, 2023Nationwide• Novartis Pharmaceuticals Corp.

Cequa Eye Solution (Sun Pharmaceutical) – Subpotent Medication (2023)

Subpotent: Out of Specification result observed for low assay

Class IIILow

FDASep 7, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Pantoprazole Sodium Injection (BE Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

Class IIModerate

FDASep 5, 2023Nationwide• BE PHARMACEUTICALS AG

Nut Diet Max Capsules (OBC Group) – Incorrect product type (2023)

Product appears to be Yellow Oleander instead of Nuez de la India as labeled.

Class IHigh

FDASep 5, 2023Nationwide• OBC GROUP CORP

Octiq Lubricating Eye Drops (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

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