FDA Recall
Terminated
Historical recordClass II
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specification: Low out of specification dissolution results.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Incorrect labeling: Incorrect or missing lot and/or exp date
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
by Apotex Inc.
- Reason
- Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
- Published
- November 6, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Great Spirits Baking Company, LLC
- Product
- Jack Daniels Tennessee Whiskey Cake - Vanilla - Net Wt 8 OZ…
- Reason
- Cakes are potentially moldy prior to their "best by" date.
- Published
- November 6, 2019
- Distribution
- Distributed to retail stores in CA, NC,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Great Spirits Baking Company, LLC
- Product
- Jack Daniels Tennessee Whiskey Cake - Pecan - Net Wt 8 OZ (2…
- Reason
- Cakes are potentially moldy prior to their "best by" date.
- Published
- November 6, 2019
- Distribution
- Distributed to retail stores in CA, NC,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Great Spirits Baking Company, LLC
- Product
- Jack Daniels Tennessee Whiskey Cake - Chocolate - Net Wt 8 O…
- Reason
- Cakes are potentially moldy prior to their "best by" date.
- Published
- November 6, 2019
- Distribution
- Distributed to retail stores in CA, NC,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of sterility assurance.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Consider Bardwell Farm Dorset cheese PLU code 97776 sliced a…
- Reason
- Potential to contain Listeria monocytogenes
- Published
- October 30, 2019
- Distribution
- NORTH ATLANTIC AND NORTHEAST WHOLE FOODS…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Newark Nut Store
- Product
- Koppers Chocolate Dark Chocolate Gummy Bears, 4oz (113g) ret…
- Reason
- Kopper s Chocolate has initiated recall of Koppers Chocolate Dark Chocolate Gummy Bears, 4oz (113g) retail package, metallized foil resealable pouch, 12 pouches per case, printed BB: 08/2020 because the product packaging only identifies soy as an allergen. The product does not list milk , which is an allergen .
- Published
- October 30, 2019
- Distribution
- The product was distributed to NY, NJ, a…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Euphoria Fancy Food Inc
- Product
- Capitan K Salmon slightly salted piece - net.wt 1.05 oz (200…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- October 30, 2019
- Distribution
- Product was distributed in NY, PA, NJ &…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dole Packaged Foods, LLC
- Product
- Dole Crushed Pineapple in 100% pineapple juice Manufactur…
- Reason
- Foreign object; potential plastic pieces.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: OK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Brain Charge Advanced…
- Reason
- Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wismettac Asian Foods, INC
- Product
- Shirakiku Buckwheat Noodles Yamaimo Soba With Concentration…
- Reason
- Product label identifies bonito, but product dipping sauce actually contains skipjack tuna, yellowfin tuna, and bluefin tuna as well as does not state the general allergen name of fish.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Roland Foods, LLC
- Product
- Roland Brand Red Caviar - Whole Grain Lumpfish (Lumpfish Roe…
- Reason
- Potential to be contaminated with Clostridium botulinum.
- Published
- October 30, 2019
- Distribution
- Products were distributed in US states:…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Roland Foods, LLC
- Product
- Roland Brand Black Caviar - Whole Grain Lumpfish (Lumpfish R…
- Reason
- Potential to be contaminated with Clostridium botulinum.
- Published
- October 30, 2019
- Distribution
- Products were distributed in US states:…
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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