FDA Recall
Ongoing
Historical recordClass I
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
by Boulla LLC
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
by Boulla LLC
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
by Boulla LLC
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
by Aurobindo Pharma USA Inc
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent drug
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- MONARCH INSTANT CHOCOLATE PUDDING & PIE FILLING MIX NATURALL…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- THIRSTER LOW CAL FRUIT, NET WT. 8.6OZ, Case UPC 507581083973…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE,…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- SYSCO VANILLA INSTANT, NET WT. 24OZ, Case UPC 10074865103791…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- SYSCO PINK LEMONADE, NET WT. 24OZ, UPC 0 74865 09326 2, Case…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- SYSCO LOW CAL LEMONADE, NET WT. 8.6OZ, Case UPC 007347301326…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- SYSCO FRUIT PUNCH, NET WT. 24OZ, Case UPC 10074865093221, DI…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- Sysco Classic Vanilla Instant Pudding & Pie Filling Mix Natu…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- Sysco Classic Strawberry Drink Mix Artificial Flavor, NET WT…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
DYMA BRANDS
- Product
- Sysco Classic Pink Lemonade Drink Mix Natural Flavor, NET WT…
- Reason
- After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
- Published
- December 11, 2024
- Distribution
- Products were distributed to the followi…
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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