DrugMar 12, 2014
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or recall — FDA D-1148-2014
Subpotent; 18 month time point
Class IIFDA: TerminatedFresenius Kabi USA, LLC
March 2014 recalls — page 5
These records include useful source details for the selected month.
DrugMar 12, 2014
Natures Pharmacy & Compounding Center Lidocaine 4% Urethral Gel recall — FDA D-1098-2014
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential…
Class IIFDA: TerminatedNatures Pharmacy & Compounding Center
DrugMar 12, 2014
HYDROXYZINE PAMOATE Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle recall — FDA D-1095-2014
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 12, 2014
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle recall — FDA D-1092-2014
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 12, 2014
Dr. Reddy's Laboratories a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid recall — FDA D-1146-2014
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 12, 2014
Aaron Industries Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid recall — FDA D-1097-2014
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Class IIIFDA: TerminatedAaron Industries Inc.
DrugMar 12, 2014
Mira Health Products METHA-DROL Extreme capsules, packaged as 60 capsules per bottle recall — FDA D-1151-2014
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Class IFDA: TerminatedMira Health Products Ltd.
DrugMar 12, 2014
Mira Health Products B-50 capsules, Healthy Life Chemistry By Purity First recall — FDA D-1149-2014
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
Class IFDA: TerminatedMira Health Products Ltd.
DrugMar 12, 2014
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND recall — FDA D-1094-2014
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 12, 2014
Hospira 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container recall — FDA D-1096-2014
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Class IIFDA: TerminatedHospira Inc.
DrugMar 12, 2014
Mira Health Products Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean recall — FDA D-1150-2014
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Class IFDA: TerminatedMira Health Products Ltd.
DrugMar 12, 2014
HYDROXYZINE PAMOATE Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx recall — FDA D-1093-2014
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
FoodMar 5, 2014
Creation Special Snack Mix 25 lb plastic bags in a cardboard recall — FDA F-1561-2014
During an inspection by the Kentucky Department for Public Health, the firm was informed that their product lacks an ingredient statement. Due to the lack of the ingredient statement the…
Class IIFDA: TerminatedCreation Gardens
FoodMar 5, 2014
The Cultured Kitchen Herb Cashew Cheese recall — FDA F-1542-2014
Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.
Class IFDA: TerminatedThe Cultured Kitchen
FoodMar 5, 2014
Natural Grocers brand Dark Chocolate Almonds recall — FDA F-1589-2014
Natural Grocers by Vitamin Cottage is recalling one lot of six ounce packages of Natural Grocers brand Dark Chocolate Almonds with the Julian packed-on date 13-351 because some bags in this…
Class IFDA: TerminatedNatural Grocers by Vitamin Cottage
FoodMar 5, 2014
The Cultured Kitchen Pepper Jack Cashew Cheese recall — FDA F-1544-2014
Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.
Class IFDA: TerminatedThe Cultured Kitchen
FoodMar 5, 2014
CSM Bakery Products NA Multifoods Bakery Products, Artificial Pistachio Flavored recall — FDA F-1571-2014
Products may contain undeclared coconut.
Class IIFDA: TerminatedCSM Bakery Products NA
FoodMar 5, 2014
The Cultured Kitchen Habanero Cilantro Lime Cashew Cheese recall — FDA F-1545-2014
Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.
Class IFDA: TerminatedThe Cultured Kitchen
FoodMar 5, 2014
CSM Bakery Products NA Multifoods Bakery Products, Cranberry Orange Muffins, 5.4oz recall — FDA F-1570-2014
Products may contain metal dust.
Class IIFDA: TerminatedCSM Bakery Products NA
FoodMar 5, 2014
The Cultured Kitchen White Cheddar Cashew Cheese recall — FDA F-1547-2014
Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.
Class IFDA: TerminatedThe Cultured Kitchen
FoodMar 5, 2014
L. M. Noodle Company Marlyce's Homemade Style Noodles, Net Wt recall — FDA F-1559-2014
L.M. Noodle Company is recalling Marlyce's Homemade Style Noodles due to an undeclared allergen. The product label does not declare "wheat" flour.
Class IIFDA: TerminatedL. M. Noodle Company, LLC
FoodMar 5, 2014
Creation Gardens Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in recall — FDA F-1560-2014
During an inspection by the Kentucky Department for Public Health, the firm was informed that their product lacks an ingredient statement. Due to the lack of the ingredient statement the…
Class IIFDA: TerminatedCreation Gardens
FoodMar 5, 2014
Bozzutos' Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz recall — FDA F-1554-2014
Bozzutos Inc. is recalling Kinnikinnick Food's bakery products due to undeclared milk.
Class IFDA: TerminatedBozzutos' Inc.
FoodMar 5, 2014
RCI Produce Cactus Leaves/Pads recall — FDA F-1558-2014
CA Dept of Pesticides tested Cactus pads and found pesticides Monocrotophos at 0.581 ppm, Carbendazim as Thiophanate Methyl at 0.510 ppm and Captan (THPI) at 0.313 ppm. There is no…
Class IIFDA: TerminatedRCI Produce
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.