FDA Recall
Terminated
Historical recordClass II
PHENYLephrine 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
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility:
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility:
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility:
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility:
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility:
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility:
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by RB Health (US) LLC
- Reason
- Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
- Published
- October 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Tolmar, Inc.
- Reason
- Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
- Published
- October 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ozona Organics LLC
- Product
- OZONA ORGANICS LIQUID PROBIOTICS & GO HEALTHY LIQUID PROBIOT…
- Reason
- Products contain high water activity in the formula that provides a potential for microbial growth.
- Published
- October 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Pharma-Natural Inc.
- Product
- Pharma Natural, Biotin 5000 mcg, Maximum Strength, Dietary S…
- Reason
- FDA sample analysis of Pharma Natural Biotin 5000 mcg Maximum Strength (30 tablets, Lot: PN10686, Exp. Date 01/24), found the biotin content was below the detection limit.
- Published
- October 4, 2023
- Distribution
- Puerto Rico
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by HUMANRACE
- Reason
- Subpotent Drug: Product does not contain SPF that is declared on the label.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by HUMANRACE
- Reason
- Subpotent Drug: Product does not contain SPF that is declared on the label.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
by Novartis Pharmaceuticals Corp.
- Reason
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent: Out of Specification result observed for low assay
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
by Aurobindo Pharma USA Inc.
- Reason
- Failed dissolution specifications - results obtained were below spec average.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).
by CareFusion 213, LLC
- Reason
- Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- 1. 7 Select Cashews Halves & Pieces Honey Roasted, Net Wt 3…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- Circle K Honey Roasted Peanuts, Net Wt 2.5 oz, UPC 194283102…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- 1. Circle K Get Up Trail Mix, Net Wt 2 oz, UPC 194283102893…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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