FDA Recall
Terminated
Historical recordClass II
Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
by Flawless Beauty LLC
- 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.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan
by Flawless Beauty LLC
- 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.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Relumins Vitamin C Solvent ampules
by Flawless Beauty LLC
- 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.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
by Flawless Beauty LLC
- 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.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
by Intrathecal Compounding Specialist, LLC
- Reason
- Lack of sterility assurance.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
by G & W Laboratories, Inc.
- Reason
- Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Panera, LLC
- Product
- Reduced-Fat Wild Blueberry Cream Cheese, 2 oz. and 8 oz.
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Panera, LLC
- Product
- Panera Reduced-Fat Honey Walnut Cream Cheese, 2 oz. and 8 oz…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Panera, LLC
- Product
- Panera Chive&Onion Reduced Fat Cream Cheese Spread, 2 oz. an…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Simply Delicious, Inc. dba Bobo's Oat Bars
- Product
- Bobo's Coconut Oat Bar 3oz. Packaged in overwrap film per…
- Reason
- Bobo's recalled Coconut 3oz Bar due to mold.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Panera, LLC
- Product
- Panera Reduced-Fat Plain Cream Cheese, 2 oz. and 8 oz.
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Panera, LLC
- Product
- Panera Plain Cream Cheese, 2 oz. and 8 oz.
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
by Baxter Healthcare Corporation
- Reason
- Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
by International Laboratories, LLC
- Reason
- LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
by Fresenius Kabi USA, LLC
- Reason
- Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 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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