FDA Recall
TerminatedTerminated: March 31, 2022Historical recordClass II
Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
by Redline Pharmacy Solutions
- Reason
- Lack Of Processing Controls
- Published
- March 18, 2020
- Distribution
- Sold to patients in Nebraska
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FDA Recall
TerminatedTerminated: March 31, 2022Historical recordClass II
Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
by Redline Pharmacy Solutions
- Reason
- Lack Of Processing Controls
- Published
- March 18, 2020
- Distribution
- Sold to patients in Nebraska
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FDA Recall
TerminatedTerminated: March 31, 2022Historical recordClass II
Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
by Redline Pharmacy Solutions
- Reason
- Lack Of Processing Controls
- Published
- March 18, 2020
- Distribution
- Sold to patients in Nebraska
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FDA Recall
TerminatedTerminated: March 31, 2022Historical recordClass II
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
by Redline Pharmacy Solutions
- Reason
- Lack Of Processing Controls
- Published
- March 18, 2020
- Distribution
- Sold to patients in Nebraska
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FDA Recall
TerminatedTerminated: March 31, 2022Historical recordClass II
Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
by Redline Pharmacy Solutions
- Reason
- Lack Of Processing Controls
- Published
- March 18, 2020
- Distribution
- Sold to patients in Nebraska
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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
View recall →
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: 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
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- William R Hill brand Soup Base Chicken, Item #41178, 1 lb, m…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- MJ Kellner brand Milk Replacer, Vegan, Soy Based, Item #8028…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- Shaver Foods brand Gravy Chicken, Item #35213, in 2 lb. meta…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- Shaver Foods brand Gravy Beef, Item #35089, in 2 lb. metalli…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- Riverside brand Brown Gravy, Item #35186, in 14 oz. metallic…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- National Food Group brand Soup Base Vegetable, Item #42526,…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- 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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