FDA Recall
Terminated
Historical recordClass II
Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500
by KRS Global Biotechnology, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
by KRS Global Biotechnology, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033
by KRS Global Biotechnology, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412
by KRS Global Biotechnology, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205
by KRS Global Biotechnology, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- October 9, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
YTM, Inc. DBA A Priori Specialty Foods
- Product
- Espinaler Razor Clams (Trimmed) 4/6 Classic Line, " N4R-LE7R…
- Reason
- An unknown object was found in a tin
- Published
- October 9, 2019
- Distribution
- North America AZ, CA, HA, IA, MA, NC,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Scenic Fruit Company
- Product
- Frozen Organic Blueberries Packed into Poly Bag, Net Weight…
- Reason
- Frozen Organic Blueberries, 3 lb. bags, are recalled due to contamination with foreign materials.
- Published
- October 9, 2019
- Distribution
- distributed in CA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
General Mills, Inc
- Product
- Gold Medal Enriched, Presifted, Unbleached All Purpose Flour…
- Reason
- 5 lb. bags of Gold Medal Unbleached All Purpose flour have the potential to be contaminated with E. coli O26:H11
- Published
- October 9, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
by Johnson Matthey Inc.
- Reason
- cGMP Deviations: Potential glass contamination
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
by Johnson Matthey Inc.
- Reason
- cGMP Deviations: Potential glass contamination
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
by Johnson Matthey Inc.
- Reason
- cGMP Deviations: Potential glass contamination
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
by Akorn, Inc.
- Reason
- cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.
by Cardinal Health dba Specialty Pharmaceutical Services
- Reason
- Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
by Darmerica, LLC
- Reason
- Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24
by Pfizer Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2
by Pfizer Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- Published
- October 2, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Decorated Red Apple Cookies sold in display case in retail s…
- Reason
- Undeclared egg
- Published
- October 2, 2019
- Distribution
- Arizona, Southern California, Hawaii and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE
- Product
- Silk Soymilk Vanilla Bag-In-Box. One, 2.5 gallon bag per…
- Reason
- Mislabeled outer box of Silk Soymilk Vanilla Bag-In-Box. Outer box incorrectly indicates the product is almond milk instead of soymilk. The internal product in box is labeled correctly as Silk Soymilk Vanilla Bag-In-Box.
- Published
- October 2, 2019
- Distribution
- The product was shipped to 3 locations o…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Star Fisheries, Inc.
- Product
- Irish Salmon Organic Atl HON; 55 lb. cases received. Fresh…
- Reason
- Firm was notified on September 11, 2019 that salmon may be contaminated with Listeria monocytogenes
- Published
- October 2, 2019
- Distribution
- Retail stores in CA only.
View recall →
FDA Recall
Terminated
Historical recordClass II
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 25, 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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