DrugNov 8, 2017
SCA Pharmaceuticals HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 recall — FDA D-0060-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
November 2017 recalls — page 11
These records include useful source details for the selected month.
DrugNov 8, 2017
SCA Pharmaceuticals fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% recall — FDA D-0062-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
Precision Dose Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups recall — FDA D-0057-2018
Subpotent Drug: low out of specification results.
Class IIIFDA: TerminatedPrecision Dose Inc.
DrugNov 8, 2017
SCA Pharmaceuticals fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl recall — FDA D-0063-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
Sanofi-Aventis U.S Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial recall — FDA D-0056-2018
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class IIIFDA: TerminatedSanofi-Aventis U.S. LLC
DrugNov 8, 2017
AVKARE Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per recall — FDA D-0055-2018
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class IIFDA: TerminatedAVKARE Inc.
FoodNov 1, 2017
Dr. Pepper Snapple Group Diet Rite, Pure Zero Cola, 0 calories, 0 caffeine, 0 sodium recall — FDA F-0030-2018
Product is labeled to be caffeine-free but contains caffeine.
Class IIFDA: TerminatedDr. Pepper Snapple Group Inc.
FoodNov 1, 2017
Beyond Better Foods ENLIGHTENED THE GOOD-FOR-YOU ICE CREAM 60 CALORIES PER SERVING recall — FDA F-0033-2018
Product contains undeclared coconut.
Class IIFDA: TerminatedBeyond Better Foods LLC
FoodNov 1, 2017
GREAT AMERICAN DELI PREMIUM CHICKEN SALAD WHEATBERRRY recall — FDA F-0039-2018
Product contains undeclared eggs and soy.
Class IFDA: TerminatedGreat American Deli, LLC
FoodNov 1, 2017
Chun Yuen Trading Co Instant Reishi Coffee, 4 in 1 recall — FDA F-0034-2018
Milk is not declared on the product labeling.
Class IFDA: TerminatedChun Yuen Trading Co., Inc.
FoodNov 1, 2017
General Mills Cascadian Farm Organic Cinnamon Raisin Granola, Net Wt 15.6 oz recall — FDA F-0037-2018
General Mills is recalling 2 production runs of Cascadian Farm Organic Cinnamon Raisin Granola due to undeclared nut allergen, almond.
Class IFDA: TerminatedGeneral Mills, Inc.
FoodNov 1, 2017
Myanmar Wholesale Trading Thanlwin Fried Bean Snack, Net Weight 227 g 8 oz recall — FDA F-0038-2018
Thanlwin Fried Bean Snack is being recalled due to undeclared peanuts.
Class IFDA: TerminatedMyanmar Wholesale Trading
FoodNov 1, 2017
Weis Markets, Inc., Ice Cream Division Sunbury, PA recall — FDA F-0035-2018
The firm is recalling their Store Made BLT sandwich due to undeclared egg found in the mayonnaise ingredient. The firm received an illness complaint reporting that egg was not declared in…
Class IFDA: TerminatedWeis Markets, Inc., Ice Cream Division
FoodNov 1, 2017
Pacific Foods of Oregon SKU 57879, Trader Joe's Organic Tomato & Roasted Red Pepper recall — FDA F-0031-2018
Product is recalled due to potential under processing.
Class IIFDA: TerminatedPacific Foods of Oregon, Inc.
DrugNov 1, 2017
Aidarex Pharmaceuticals ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles recall — FDA D-0053-2018
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class IIIFDA: TerminatedAidarex Pharmaceuticals LLC
DrugNov 1, 2017
AbbVie AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone recall — FDA D-0033-2018
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class IIIFDA: TerminatedAbbVie Inc.
DrugNov 1, 2017
Vi-Jon Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) recall — FDA D-0073-2018
Failed Stability Specifications
Class IIIFDA: TerminatedVi-Jon, Inc.
DrugNov 1, 2017
Intralipid 20%, A 20% I.V recall — FDA D-0030-2018
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to…
Class IFDA: TerminatedBaxter Healthcare Corporation
DrugNov 1, 2017
Becton Dickinson & Company ChloraPrep OneStep (Clear) recall — FDA D-0029-2018
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Class IIFDA: TerminatedBecton Dickinson & Company
DrugNov 1, 2017
Wockhardt Usa Enalapril Maleate tablets, USP, 5mg, 1000-count bottles recall — FDA D-0051-2018
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class IIIFDA: TerminatedWockhardt Usa Inc.
DrugNov 1, 2017
Vitility MAN OF STEEL capsules, 3000mgs/grain, 1-count packets recall — FDA D-0032-2018
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an…
Class IFDA: TerminatedVitility
DrugNov 1, 2017
Fluocinonide Gel USP, 0.05%, 15 g tube recall — FDA D-0146-2018
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class IIIFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.