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
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 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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Truck Farm, LLC
- Product
- Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix.…
- Reason
- The product contains wheat flour, but does not declare wheat on the label.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
by Ingenus Pharmaceuticals Llc
- Reason
- Crystallization: Presence of particulate matter identified as API crystallization
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
by Aurobindo Pharma USA Inc.
- Reason
- Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
by KVK-Tech, Inc.
- Reason
- Presence of Foreign Substance; Fiber particles.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Market Sandwich Artisan Style Albacore Tuna Salad on Dark Wh…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Tuna Salad on Wheat Bread, Keep Refrigerated. packaged un…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Deli Express Tuna Salad on Cracked Wheat Bread, Net Wt 5.0 o…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- archer farms Turkey & Havarti sandwich on wheat bread Net W…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Market Sandwich Ranch chicken Salad on a Croissant. Net Wt.…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Market Sandwich Everything Bagel with Smoked Ham, Smoked Whi…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Market Sandwich Dill Egg Salad on Classic White Bread, Net W…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Deli Express Egg Salad on Homestyle White Bread, Net Wt. 4.8…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 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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