Drugs Recalls - RecallPedia

Relumins Vitamin C Solvent ampules

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30

Hetero Labs, Ltd. - Unit III

Class I - Dangerous

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Jan 10, 2018 Prescription Drugs View Details →

Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

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.

Intrathecal Compounding Specialist

Class I - Dangerous

Lack of sterility assurance.

Nov 30, 2017 Compounded Drugs Nationwide View Details →

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.

G & W Laboratories

Class I - Dangerous

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

Jan 19, 2018 Prescription Drugs Nationwide View Details →

VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals, Inc., Cambridge, MA 02139-4234, NDC 63020-0049-01

Millennium Pharmaceuticals

Class I - Dangerous

Defective Container: Confirmed reports of loose vial crimps.

Jan 30, 2018 Prescription Drugs Nationwide View Details →

Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Jan 29, 2018 Prescription Drugs Nationwide View Details →

Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20

Aurobindo Pharma

Class I - Dangerous

Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

Jan 2, 2018 Prescription Drugs Nationwide View Details →

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.

Intrathecal Compounding Specialist

Class I - Dangerous

Lack of sterility assurance.

Nov 30, 2017 Compounded Drugs Nationwide View Details →

Reiki Glutathione Whitening kits

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

AuroMedics Pharma

Class I - Dangerous

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

Dec 20, 2017 Prescription Drugs View Details →

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00

AuroMedics Pharma

Class I - Dangerous

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

Dec 4, 2017 Prescription Drugs Nationwide View Details →

Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Jan 29, 2018 Prescription Drugs Nationwide View Details →

Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Jan 29, 2018 Prescription Drugs Nationwide View Details →

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.

Intrathecal Compounding Specialist

Class I - Dangerous

Lack of sterility assurance.

Nov 30, 2017 Compounded Drugs Nationwide View Details →

Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Other Drugs Nationwide View Details →

TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy

Flawless Beauty

Class I - Dangerous

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.

Jan 19, 2018 Prescription Drugs Nationwide View Details →