FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
by Johnson Matthey Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Better Made Snack Foods Inc.
- Product
- Better Made Snack Foods Family Size $3.99 Original Potato Ch…
- Reason
- Undeclared milk
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fungi Perfecti LLC
- Product
- Host Defense MycoBotanicals Blood Sugar, dietary supplement,…
- Reason
- Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
by Ata International Inc
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
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
Terminated
Historical 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
View recall →
FDA Recall
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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
View recall →
FDA Recall
Terminated
Historical 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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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
View recall →
FDA Recall
Terminated
Historical 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
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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