FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Cookies-N-Cream, Organic Frozen Custard, Contents:…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Coconut, Organic Frozen Custard, Contents: One U.S.…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Chocolate Chip Cookie Dough, Organic Frozen Custard,…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Salted Chocolate Caramel Crunch, Organic Frozen Cust…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Rhubarb, Organic Frozen Custard, Contents: One U.S.…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Peach Cream, Organic Frozen Custard, Contents: One…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Maple Cream, Organic Frozen Custard, Contents: One…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barron County Organics
- Product
- 20 Mile Black Cherry Organic Frozen Custard, Contents: One…
- Reason
- Ingredients were not pasteurized after blending as required by State of Wisconsin.
- Published
- February 24, 2021
- Distribution
- MN and WI
View recall →
FDA Recall
Ongoing
Historical recordClass I
Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label)
by Apotex Corp.
- Reason
- Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)
by Apotex Corp.
- Reason
- Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211
by Stanley Specialty Pharmacy Compounding and Wellness Center
- Reason
- Superpotent Drug. Lidocaine higher concentration than listed
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurity/Degradation Specifications
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
by ACCORD HEALTHCARE, INC.
- Reason
- Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Glanbia Performance Nutrition (Manufacturing), Inc
- Product
- think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumbl…
- Reason
- Undeclared ingredients including but not limited to pecans and almonds
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Finer Foods, Inc.
- Product
- Reese Hollandaise Sauce packaged in glass jars 7.5 oz UPC: 7…
- Reason
- Reports of compromised vacuum seal and product expansion which may lead to growth of microorganisms
- Published
- February 17, 2021
- Distribution
- Distributed to distribution centers in C…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Finer Foods, Inc.
- Product
- Reese Bearnaise Sauce packaged in glass jars 7.5 oz UPC: 706…
- Reason
- Reports of compromised vacuum seal and product expansion which may lead to growth of microorganisms
- Published
- February 17, 2021
- Distribution
- Distributed to distribution centers in C…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
by Nostrum Laboratories Inc
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01
by AuroMedics Pharma LLC
- Reason
- Discoloration and failed pH specifications
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- CGMP deviations.
- Published
- February 10, 2021
- 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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