FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 6, 2020Historical recordClass III
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
by Ingenus Pharmaceuticals Llc
- Reason
- Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 1, 2020Historical recordClass II
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Hometown Food Company
- Product
- Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper…
- Reason
- Product may be contaminated with Salmonella
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 4, 2021Historical recordClass II
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Subpotent Drug.
- Published
- March 27, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 7, 2020Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2020Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2020Historical recordClass II
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 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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