FDA Recall
Terminated
Historical recordClass II
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
by Fresenius Kabi USA LLC
- Reason
- Low out of specification results for epinephrine assay.
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
by Genentech Inc
- Reason
- Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
by Alvogen, Inc
- Reason
- Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Heritage Family Specialty Foods, Inc.
- Product
- E6164J2 Taco Casa Green Salsa 8 x 4 lb (1.8 kg) pouches
- Reason
- Potential to contain a foreign material
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Heritage Family Specialty Foods, Inc.
- Product
- Hatch Verde Salsa Medium Net Wt. 12 oz (340g) 6 jars per cas…
- Reason
- Potential to contain a foreign material
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
by HOYU(US) LOGISTICS INC
- Reason
- Subpotent
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
by NSNY Distributor Inc
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
by NSNY Distributor Inc
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Leavitt Corporation
- Product
- URBAN MEADOW brand DRY ROASTED UNSALTED PEANUTS; NET WT 16OZ…
- Reason
- Product may contain high levels of aflatoxin.
- Published
- July 7, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by Japan Portobello, Mushrooms, Sweet Pota…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by India Curry, Broccoli, Cauliflower, Coc…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by Mexico Roasted Poblanos, Ancho Chilli P…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by America Roasted Potato, Dill, Chives, R…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
by VIONA PHARMACEUTICALS INC
- Reason
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
by Bausch Health Companies, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
by Bausch Health Companies, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 30, 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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