Date: 20150903
Status: Terminated
Reason: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Classification: Class II
Date: 20200730
Status: Ongoing
Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Classification: Class II
Date: 20200522
Status: Terminated
Reason: Some bottles may contain mixed strengths of the product.
Classification: Class II
Date: 20211026
Status: Terminated
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Classification: Class II
Date: 20160505
Status: Terminated
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Classification: Class II
Date: 20140708
Status: Terminated
Reason: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Classification: Class III
Date: 20240620
Status: Ongoing
Reason: CGMP deviations
Classification: Class II
Date: 20180910
Status: Terminated
Reason: Lack of Assurance of Sterility
Classification: Class II
Date: 20130913
Status: Terminated
Reason: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Classification: Class II
Date: 20170619
Status: Terminated
Reason: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Classification: Class II
Date: 20210315
Status: Terminated
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Classification: Class II
Date: 20150602
Status: Terminated
Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Classification: Class II
Date: 20131107
Status: Terminated
Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Classification: Class II
Date: 20220126
Status: Terminated
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Classification: Class II
Date: 20180803
Status: Terminated
Reason: Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Classification: Class I
Date: 20171116
Status: Terminated
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Classification: Class II
Date: 20221227
Status: Completed
Reason: Lack of sterility assurance
Classification: Class II
Date: 20150602
Status: Terminated
Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Classification: Class II
Date: 20130702
Status: Terminated
Reason: Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Classification: Class II
Date: 20180119
Status: Terminated
Reason: Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Classification: Class II
Date: 20160808
Status: Terminated
Reason: Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.
Classification: Class II
Date: 20160831
Status: Terminated
Reason: Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, peanut oil.
Classification: Class II
Date: 20141010
Status: Terminated
Reason: Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date.
Classification: Class I
Date: 20120727
Status: Terminated
Reason: FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes.
Classification: Class I
Date: 20200224
Status: Terminated
Reason: Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
Classification: Class III
Date: 20180525
Status: Terminated
Reason: Coffee Toffee is recalled because pecan is listed on the Ingredients statement but it is not listed in the Contains statement.
Classification: Class III
Date: 20200401
Status: Terminated
Reason: Product contains dried peaches, but front labeling of product stated dried plums
Classification: Class III
Date: 20170505
Status: Terminated
Reason: The firm stated that the product contains undeclared allergens.
Classification: Class II
Date: 20141209
Status: Terminated
Reason: Possible contamination with Listeria monocytogenes.
Classification: Class I
Date: 20220106
Status: Terminated
Reason: Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes.
Classification: Class I
Date: 20140626
Status: Terminated
Reason: Undeclared Allergen; Peanuts.
Classification: Class I
Date: 20180327
Status: Terminated
Reason: Shipping container from CA to HI was not held at proper temperature which could cause food items to be contaminated with spoilage organisms or pathogens
Classification: Class II
Date: 20171214
Status: Terminated
Reason: Nyblad Orchards Inc. initiated a voluntary recall of multiple varieties of whole fresh apples due to potential contamination with Listeria monocytogenes.
Classification: Class I
Date: 20220428
Status: Terminated
Reason: Products may potentially contain one or more of the following undeclared tree nuts: Pecans, Almonds, Coconut, Macadamia Nuts, & Walnuts.
Classification: Class II
Date: 20240503
Status: Ongoing
Reason: Potential salmonella contamination
Classification: Class I
Date: 20180212
Status: Terminated
Reason: Sharp edges were observed on several of the cans which have the potential of causing cuts on the mouths of consumers who use the product.
Classification: Class II
Date: 20220428
Status: Terminated
Reason: Potential contamination with Salmonella
Classification: Class I
Date: 20240209
Status: Ongoing
Reason: Product recalled due to the presence of yellow oleander and its components in the product.
Classification: Class I
Date: 20140725
Status: Terminated
Reason: Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.
Classification: Class I
Date: 20230718
Status: Terminated
Reason: Undeclared Allergen - Soy Flour
Classification: Class II