FDA Recall
TerminatedTerminated: January 17, 2024Historical recordClass II
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433
by H J Harkins Company Inc dba Pharma Pac
- Reason
- Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 17, 2022Historical recordClass II
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
by Precision Dose Inc.
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 4, 2022Historical recordClass II
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
by American Health Packaging
- Reason
- CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 28, 2021Historical recordClass II
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
by Mayne Pharma Inc
- Reason
- Product Mix-Up: A foreign tablet was found in bottle.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 19, 2020Historical recordClass II
Stonewall Kitchen, LLC
- Product
- Stonewall Kitchen, Ghost Pepper Salsa, Net Weight 454g (16oz…
- Reason
- Product is mislabeled as salsa but it contains queso and does not declare two allergens, specifically milk and soy.
- Published
- March 18, 2020
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 11, 2020Historical recordClass II
Maryland Packaging, LTD.
- Product
- Pure Cane Granulated Sugar, Single 10 lb. package, 156 paper…
- Reason
- Possible foreign object: metal wire
- Published
- March 18, 2020
- Distribution
- The product was distributed to PA and MD
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2020Historical recordClass II
GARZA FOOD VENTURES
- Product
- Siete Grain Free Burrito Size Tortillas Net Wt 15 oz (423g)…
- Reason
- Sodium level in the product 340 mg per serving, instead of the 15 mg declared on the label.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 28, 2022Historical recordClass II
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
by Pfizer Inc.
- Reason
- Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
- Published
- March 11, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2023Historical recordClass II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- 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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