FDA Recall
TerminatedTerminated: February 5, 2021Historical recordClass I
Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
by Darmerica, LLC
- Reason
- Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
- Published
- October 2, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 10, 2023Historical recordClass III
Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24
by Pfizer Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- Published
- October 2, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 10, 2023Historical recordClass III
ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2
by Pfizer Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- Published
- October 2, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 16, 2022Historical recordClass II
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 15, 2022Historical recordClass II
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
by West-Ward Columbus Inc
- Reason
- Failed Impurities/Degradation Specificattion
- Published
- September 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 3, 2020Historical recordClass II
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
by Torrent Pharma Inc.
- Reason
- Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
- Published
- September 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 12, 2023Historical recordClass II
Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
by Ridge Properties, LLC
- Reason
- Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
- Published
- September 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 12, 2023Historical recordClass II
Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
by Ridge Properties, LLC
- Reason
- Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
- Published
- September 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 12, 2023Historical recordClass II
Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
by Ridge Properties, LLC
- Reason
- Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
- Published
- September 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 12, 2023Historical recordClass II
Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
by Ridge Properties, LLC
- Reason
- Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
- Published
- September 25, 2019
- 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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