FDA Recall
TerminatedTerminated: June 30, 2021Historical recordClass II
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
by Lupin Pharmaceuticals Inc.
- Reason
- Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
- Published
- July 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 19, 2022Historical recordClass III
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
by Fresenius Kabi USA, LLC
- Reason
- Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
- Published
- July 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 17, 2024Historical recordClass II
Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
- Published
- July 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 8, 2021Historical recordClass II
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
by Keryx Biopharmaceuticals, Inc.
- Reason
- cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
- Published
- July 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 28, 2022Historical recordClass III
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
by Akorn, Inc.
- Reason
- Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
- Published
- July 22, 2020
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
by Granules Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 22, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Wholesome Pantry Organic Sesame Asian Salad Kit 13 oz., UPC…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Wholesome Pantry Organic Chopped Sesame Asian Salad Kit 10.9…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Signature Farms Premium Romaine 9 oz., UPC 021130419166, Ice…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Signature Farms Green & Crisp 11 oz., UPC 021130419128, Iceb…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Signature Farms Lettuce Shreds 8 oz., UPC 021130112180, Ice…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Signature Farms Garden Salad 12 oz., UPC 021130981359, Icebe…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Signature Farms Coleslaw 3 Color 14 oz., UPC 021130111691, G…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Tri-Color Cole Slaw 16 oz., UPC 681131387484, Gre…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Shredded Iceberg Lettuce 8 oz., UPC 681131328968,…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Shredded Iceberg Lettuce 16 oz., UPC 681131532099…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Premium Romaine Salad 9 oz., UPC 681131387538, R…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Premium Romaine Salad 18 oz., UPC 681131388078,…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Kale Slaw 12 oz., UPC 681131221573, Broccoli sta…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 16, 2020Historical recordClass II
Fresh Express Incorporated
- Product
- Marketside Crisp Greens 12 oz., UPC 681131387552, Romaine le…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
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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