FDA Recall
Terminated
Historical recordClass II
S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Substance
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Azuma Foods International Inc USA
- Product
- Frozen Saba Misozuke; (seasoned Mackerel) Product # 51108,…
- Reason
- Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes.
- Published
- November 13, 2019
- Distribution
- HI only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Azuma Foods International Inc USA
- Product
- Salmon Misozuke; Seasoned Atlantic Salmon Product # 51104;…
- Reason
- Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes.
- Published
- November 13, 2019
- Distribution
- HI only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Azuma Foods International Inc USA
- Product
- Teriyaki Grilled Calamari, (Grilled Squid with Teriyaki Sauc…
- Reason
- Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes.
- Published
- November 13, 2019
- Distribution
- HI only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Azuma Foods International Inc USA
- Product
- Frozen Ika Popo (Sugata Yaki); Product # 51106 16 pkg/0.46…
- Reason
- Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes.
- Published
- November 13, 2019
- Distribution
- HI only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Images Unlimited Products, dba Cellect Products
- Product
- CELLECT brand and ESSENTIALS FACTOR Cell Synergy brand Unfla…
- Reason
- Product contains unsafe levels of Arsenic and Lead
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
by AuroMedics Pharma LLC
- Reason
- CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 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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