FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Professional Botanicals
- Product
- Professional Botanicals MealPlex (756 grams) and Veo Natural…
- Reason
- Professional Botanicals announces a voluntary field action for MealPlex and Pearl due to undeclared milk allergen.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Rich Products Corp
- Product
- New York Style Chocolate Iced ¿clairs under the following la…
- Reason
- Products were recalled due to the potential presence of plastic foreign material.
- Published
- November 16, 2016
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Truco Enterprises, Inc
- Product
- On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. p…
- Reason
- Possible metal fragments in corn flour.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Truco Enterprises, Inc
- Product
- On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. pa…
- Reason
- Possible metal fragments in corn flour.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
by Akorn Inc
- Reason
- Subpotent Drug: concentration of product is less than labeled amount.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
by Actavis Laboratories, FL, Inc.
- Reason
- Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vitalicious Acquisition
- Product
- VitaTops Apple Crumb, NET WT. 2 oz. (55g), packed in a clear…
- Reason
- The affected lots of VitaTops Apple Crumb contain undeclared milk.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Roland Foods, LLC.
- Product
- Roland¿ Preserved Lemons, NET WT. 12.35 OZ., and Roland¿ PRE…
- Reason
- The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
by Janssen Ortho L.L.C.
- Reason
- Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
- Published
- November 2, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
- Published
- November 2, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
- Published
- November 2, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wilton Brands.
- Product
- Wilton Teal Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
- Reason
- Airbrush color has the potential to be contaminated with mold, yeast or bacteria.
- Published
- November 2, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wilton Brands.
- Product
- Wilton Purple Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
- Reason
- Airbrush color has the potential to be contaminated with mold, yeast or bacteria.
- Published
- November 2, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wilton Brands.
- Product
- Wilton Pink Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
- Reason
- Airbrush color has the potential to be contaminated with mold, yeast or bacteria.
- Published
- November 2, 2016
- 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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