US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated

TP Drug Laboratories Vitamin C ampules

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.

Flawless Beauty LLC D-0331-2018
Class II · Moderate risk Terminated

Reiki Glutathione Whitening kits

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.

Flawless Beauty LLC D-0330-2018
Class II · Moderate risk Terminated

Laennec INJ

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.

Flawless Beauty LLC D-0329-2018
Class II · Moderate risk Terminated

Tationil Glutathione

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.

Flawless Beauty LLC D-0328-2018
Class II · Moderate risk Terminated

Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm

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.

Flawless Beauty LLC D-0327-2018
Class II · Moderate risk Terminated

Tatiomax Gluatathione Whitening kits

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.

Flawless Beauty LLC D-0326-2018
Class II · Moderate risk Terminated

Relumins Vitamin C Solvent ampules

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.

Flawless Beauty LLC D-0325-2018
Class II · Moderate risk Terminated

Relumins Advanced Glutathione kits

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.

Flawless Beauty LLC D-0324-2018
Class III · Low risk Terminated

Ciclopirox Olamine Cream USP

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

G & W Laboratories, Inc. NDC 0713-0638-15 D-0250-2018
Class I · High risk Terminated

Senna Laxative

Reason Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.

Magno Humphries Laboratories, Inc D-0342-2018
Class III · Low risk Terminated

Vecuronium bromide for Injection

Reason Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Fresenius Kabi USA, LLC NDC 63323-781-10 D-0426-2018
Class I · High risk Terminated

Hcg 5

Reason Non-Sterility

The Compounding Pharmacy of America D-0600-2018
Class I · High risk Terminated

Levofloxacin in 5% Dextrose Injection

Reason Presence of Particulate Matter; contains visible particulate matter identified as mold.

AuroMedics Pharma LLC NDC 55150-243-46 D-0574-2018
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets

Reason Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

International Laboratories, Inc. NDC 54458-926-16 D-0234-2018
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets

Reason Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

International Laboratories, Inc. NDC 54458-927-16 D-0233-2018
Class II · Moderate risk Terminated

Ibuprofen Caplets USP 200 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 53943-292-15 D-0695-2018
Class II · Moderate risk Terminated

Ibuprofen Caplets USP 200 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-600-05 D-0694-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 800 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-113-10 D-0693-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 800 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-604-01 D-0692-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 600 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-112-01 D-0691-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 600 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-112-10 D-0690-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 600 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-603-01 D-0689-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 400 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 42582-111-18 D-0688-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets USP 400 mg

Reason CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Time-Cap Laboratories, Inc. NDC 49483-602-01 D-0687-2018