🍔 Food 💊 Drugs 🏥 Medical Devices
PHENYLephrine 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 Class II

Reason: Lack of assurance of sterility:

Central Admixture Pharmacy Services Inc 20230921 Terminated
Distributed: Nationwide in the USA
View Details
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1 Class II

Reason: Lack of assurance of sterility:

Central Admixture Pharmacy Services Inc 20230921 Terminated
Distributed: Nationwide in the USA
View Details
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1 Class II

Reason: Lack of assurance of sterility:

Central Admixture Pharmacy Services Inc 20230921 Terminated
Distributed: Nationwide in the USA
View Details
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1 Class II

Reason: Lack of assurance of sterility:

Central Admixture Pharmacy Services Inc 20230921 Terminated
Distributed: Nationwide in the USA
View Details
fentaNYL 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 71286-2071-7 Class II

Reason: Lack of assurance of sterility:

Central Admixture Pharmacy Services Inc 20230921 Terminated
Distributed: Nationwide in the USA
View Details
Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90 Class III

Reason: Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.

RB Health (US) LLC 20230829 Terminated
Distributed: USA nationwide
View Details
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526. Class III

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

Tolmar, Inc. 20230912 Terminated
Distributed: Nationwide in the US.
View Details
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50 Class II

Reason: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Sofie Co dba Sofie 20230822 Terminated
Distributed: Product was released to one facility in VA.
View Details
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002 Class II

Reason: Subpotent Drug: Product does not contain SPF that is declared on the label.

HUMANRACE 20230818 Ongoing
Distributed: Nationwide in the USA, Spain, Italy, UK, and France.
View Details
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01 Class II

Reason: Subpotent Drug: Product does not contain SPF that is declared on the label.

HUMANRACE 20230818 Ongoing
Distributed: Nationwide in the USA, Spain, Italy, UK, and France.
View Details
Page 226 of 1,805 | Showing 10 recalls
Data provided by openFDA