FDA Recall
Terminated
Historical recordClass II
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- PRIVATE SELECTION FROZEN BLACKBERRIES in 16 oz. bags, 10 bag…
- Reason
- Potential norovirus contamination.
- Published
- April 15, 2020
- Distribution
- Product was distributed to the following…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- PRIVATE SELECTION FROZEN BERRY MEDLEY in 16 oz. (10 bags per…
- Reason
- Potential norovirus contamination.
- Published
- April 15, 2020
- Distribution
- Product was distributed to the following…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lindt & Sprungli (USA), Inc.
- Product
- Lindt & Sprungli (USA), Inc.; Excellence 85% Cocoa Dark Choc…
- Reason
- Chocolate contains undeclared milk and soy
- Published
- April 15, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
by Akorn Inc
- Reason
- Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Defective Container: Recall is due to breaking and shattering of ampules upon opening
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Vitamin Cottage Natural Food Markets, Inc.
- Product
- NATURAL GROCERS ALMOND CLUSTERS DK CHOCOLATE NON-GMO, 8 oz.…
- Reason
- Undeclared peanut and milk allergens
- Published
- April 8, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Vitamin Cottage Natural Food Markets, Inc.
- Product
- NATURAL GROCERS PEANUT CLUSTERS DK CHOCOLATE NON-GMO, 8 oz.…
- Reason
- Undeclared almond and milk allergens
- Published
- April 8, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Advanced Fresh Concepts Corp
- Product
- Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0…
- Reason
- Firm testing found Vibrio parahaemolyticus in cooked butterfly shrimp from Thailand.
- Published
- April 8, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
New Capstone, Inc
- Product
- ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G…
- Reason
- The firm was notified that the labeling does not include the word milk on the ingredient statement
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- SubPotent Drug: Low out-of-specification results for assay testing.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
by Grato Holdings, Inc.
- Reason
- Labeling mix-up - Indications on product label are incorrect.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Southern Sisters Gourmet
- Product
- Southern Sisters Gourmet Crab Cake Mix, Net Wt 96 g (3.38 oz…
- Reason
- Undeclared allergens: Wheat and Soy
- Published
- April 1, 2020
- Distribution
- Distributed in the states of AL, AR, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Southern Sisters Gourmet
- Product
- Southern Sisters Gourmet Butter Pecan Cheeseball mix, Net Wt…
- Reason
- Undeclared allergens: Milk, Wheat, Soy, and Almond.
- Published
- April 1, 2020
- Distribution
- Distributed in the states of AL, AR, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Southern Sisters Gourmet
- Product
- Southern Sisters Gourmet Taco Soup, Net Wt- Pkg 1: 191.65 g…
- Reason
- Undeclared allergens: Milk and Soy
- Published
- April 1, 2020
- Distribution
- Distributed in the states of AL, AR, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Southern Sisters Gourmet
- Product
- Southern Sisters Gourmet Oven Fried Chicken, Net Wt 2.6 oz/7…
- Reason
- Undeclared allergen: Wheat
- Published
- April 1, 2020
- Distribution
- Distributed in the states of AL, AR, FL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Southern Sisters Gourmet
- Product
- Southern Sisters Gourmet Shrimp and Stone-Ground Grits, Seas…
- Reason
- Undeclared allergen: Milk. Undeclared colors: Yellow #5 and #6.
- Published
- April 1, 2020
- Distribution
- Distributed in the states of AL, AR, FL,…
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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