FDA Recall
Terminated
Historical recordClass II
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
by Aire-Master of America Inc
- Reason
- CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- Published
- August 24, 2022
- Distribution
- Florida, Illinois, Iowa, New Jersey
View recall →
FDA Recall
Terminated
Historical recordClass II
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
by Aire-Master of America Inc
- Reason
- CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- Published
- August 24, 2022
- Distribution
- Florida, Illinois, Iowa, New Jersey
View recall →
FDA Recall
Terminated
Historical recordClass II
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
by Aire-Master of America Inc
- Reason
- CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- Published
- August 24, 2022
- Distribution
- Florida, Illinois, Iowa, New Jersey
View recall →
FDA Recall
Terminated
Historical recordClass II
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
by Aire-Master of America Inc
- Reason
- CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- Published
- August 24, 2022
- Distribution
- Florida, Illinois, Iowa, New Jersey
View recall →
FDA Recall
Terminated
Historical recordClass II
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
by Nephron Sc Inc
- Reason
- cGMP Deviations: deviations leading to potential cross-contamination.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
by Amerisource Health Services LLC
- Reason
- Subpotent Drug
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
by Baxter Healthcare Corporation
- Reason
- Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
by HERON THERAPEUTICS, INC.
- Reason
- Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SWEET LOREN'S
- Product
- Sweet Loren's Place and Bake Sugar Cookie Dough, Net Wt. 12…
- Reason
- Gluten free labeled cookie dough contains gluten
- Published
- August 24, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Blue Diamond Growers
- Product
- Whole Brown Almonds (bulk)
- Reason
- Firm's internal sampling identified a positive Salmonella result on Item 00113 that was on hand at the firm on 7/15/2022. Firm elected to hold all inventory between the sanitation break from 7/5/2022 - 7/18/2022. Some product from within that time frame was shipped to customers. Although none of the products on the recall list tested positive for Salmonella, out of an abundance of caution the firm elected to proceed with a recall on the shipped products.
- Published
- August 24, 2022
- Distribution
- U.S distribution to the following Califo…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Albertsons Companies LLC
- Product
- Ready Meals Crab & Shrimp w/Ccktl SCE NET WT 12 OZ CAL 310…
- Reason
- Undeclared allergens; fish, shellfish, egg, wheat, and soy
- Published
- August 24, 2022
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Albertsons Companies LLC
- Product
- Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 O…
- Reason
- Undeclared allergens; fish, shellfish, egg, and wheat
- Published
- August 24, 2022
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Albertsons Companies LLC
- Product
- Ready Meals Shrimp Cooked with Cocktail Sauce SCE NET WT 12…
- Reason
- Undeclared allergens; fish and shellfish
- Published
- August 24, 2022
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilbur's Of Maine Chocolate Confections
- Product
- Wilbur's of Maine Milk Chocolate Covered Blueberries
- Reason
- Product contains undeclared almonds.
- Published
- August 24, 2022
- 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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