FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
by Wockhardt Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
by Wockhardt Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pinnacle Food Group, Llc
- Product
- Wish Bone House Italian Salad Dressing 15 oz.
- Reason
- The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg not declared on the bottle.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Talking Rain Beverage Co Inc
- Product
- Sparkling ICE Cherry Limeade Naturally Flavored Sparking Wat…
- Reason
- Sparkling ICE Cherry Limeade, 17 oz. bottles, is recalled after the firm received a small number of customer complaints that reported an off-taste and off-odor of the product.
- Published
- July 18, 2018
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
Terminated
Historical recordClass I
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
by Fagron Compounding Services LLC dba Fagron Sterile Services
- Reason
- Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
by Fagron Compounding Services LLC dba Fagron Sterile Services
- Reason
- Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
by LUPIN SOMERSET
- Reason
- Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
by Qualgen, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
by Qualgen, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
by Ingenus Pharmaceuticals Llc
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
by Ingenus Pharmaceuticals Llc
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Utz Quality Food Inc
- Product
- Good Health Organic Tortillas; Black Bean & Rice; Net Wt 5.5…
- Reason
- Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen.
- Published
- July 4, 2018
- Distribution
- AL AL AR AZ CT DC DE FL GA IL…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Utz Quality Food Inc
- Product
- Golden Flake TORTIYAHS! Superior Dipping Chips; Net Wt 12.5…
- Reason
- Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen.
- Published
- July 4, 2018
- Distribution
- AL AL AR AZ CT DC DE FL GA IL…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Utz Quality Food Inc
- Product
- Weis Signature Collection No Salt Added White Corn Tortilla…
- Reason
- Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen.
- Published
- July 4, 2018
- Distribution
- AL AL AR AZ CT DC DE FL GA IL…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Utz Quality Food Inc
- Product
- Utz Organic Yellow Corn Tortillas, Net Wt 9 oz; UTZ Quality…
- Reason
- Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen.
- Published
- July 4, 2018
- Distribution
- AL AL AR AZ CT DC DE FL GA IL…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Utz Quality Food Inc
- Product
- Utz Organic Blue Corn Tortillas; Net Wt 9 oz; UTZ Quality Fo…
- Reason
- Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen.
- Published
- July 4, 2018
- Distribution
- AL AL AR AZ CT DC DE FL GA IL…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Utz Quality Food Inc
- Product
- Utz Restaurant Style Tortilla Chips; Net Wt 17 oz; White Cor…
- Reason
- Utz Quality Foods, LLC, is voluntarily recalling select expiration dates of some Golden Flake, Good Health, Utz and Weis Brand Tortilla Chip items due to potential contamination of undeclared milk allergen.
- Published
- July 4, 2018
- Distribution
- AL AL AR AZ CT DC DE FL GA IL…
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 27, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 27, 2018
- 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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