FDA Recall
TerminatedTerminated: March 29, 2018Historical recordClass II
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
by Amgen, Inc.
- Reason
- Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 24, 2020Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 24, 2020Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 24, 2020Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 24, 2020Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 19, 2023Historical recordClass II
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
by Pfizer Inc.
- Reason
- Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
- Published
- September 27, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 19, 2023Historical recordClass II
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
by Pfizer Inc.
- Reason
- Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
- Published
- September 27, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 13, 2020Historical recordClass II
Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 13, 2020Historical recordClass II
Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
by PharMEDium Services, LLC
- Reason
- Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
- Published
- September 27, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 11, 2019Historical recordClass III
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-25.
by Pfizer Inc.
- Reason
- Failed Dissolution Specifications
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 11, 2019Historical recordClass III
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.
by Pfizer Inc.
- Reason
- Failed Dissolution Specifications
- Published
- September 27, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 16, 2018Historical recordClass II
Dedinas Franzak Enterprises dba Cheeze Kurls Inc.c.
- Product
- Big Win Butter Popcorn, 5 oz., Butter Popcorn Artificially F…
- Reason
- Dedinas Franzak Enterprises dba Cheeze Kurls Inc. initiated a voluntary recall of Big Win Butter Popcorn, 5 oz., Butter Popcorn Artificially Flavored due to undeclared allergen milk.
- Published
- September 27, 2017
- Distribution
- Domestic only: California, Indiana, Virg…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 11, 2018Historical recordClass II
NOW Foods
- Product
- Organic Coconut Sugar, 16oz bag, 12 bags/case, packed in a f…
- Reason
- Undeclared gluten found in the product and the product is labeled "Gluten Free".
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 18, 2019Historical recordClass II
House of Spices India, Inc.
- Product
- Laxmi Rusks, 10.58 OZ (300 gram) bags; UPC Code: 7 23246 264…
- Reason
- Product may contain undeclared soy.
- Published
- September 27, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 21, 2017Historical recordClass II
The Coca-Cola Company
- Product
- Honest Kids Juice Slushy Blueberry Punch, 3.5-oz. pouch, UPC…
- Reason
- Due to a potential package design issue, there is the possibility for consumers to be injured when consuming the product from an unevenly opened pouch.
- Published
- September 27, 2017
- Distribution
- AR, AZ, CA, CO, GA, FL IL, IN, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 3, 2018Historical recordClass II
Kilby Cream
- Product
- Kilby Cream Ice Cream Various Flavors: , Vanilla Chip Siz…
- Reason
- According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.
- Published
- September 27, 2017
- Distribution
- Product was distributed in MD, PA, and D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 3, 2018Historical recordClass II
Kilby Cream
- Product
- Kilby Cream Ice Cream Various Flavors: , Vanilla Size: 2.…
- Reason
- According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.
- Published
- September 27, 2017
- Distribution
- Product was distributed in MD, PA, and D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 3, 2018Historical recordClass II
Kilby Cream
- Product
- Kilby Cream Ice Cream Various Flavors: , Tracker Tracks S…
- Reason
- According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.
- Published
- September 27, 2017
- Distribution
- Product was distributed in MD, PA, and D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 3, 2018Historical recordClass II
Kilby Cream
- Product
- Kilby Cream Ice Cream Various Flavors: , Sweet Cream Siz…
- Reason
- According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.
- Published
- September 27, 2017
- Distribution
- Product was distributed in MD, PA, and D…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 3, 2018Historical recordClass II
Kilby Cream
- Product
- Kilby Cream Ice Cream Various Flavors: Strawberry Cheesecake…
- Reason
- According to the firm a process deviation and proper temperatures were not reached during ice cream production and mix storage.
- Published
- September 27, 2017
- Distribution
- Product was distributed in MD, PA, and D…
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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