US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Dexpanthenol 250mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1178-2016
Class II · Moderate risk Terminated

Cesium Chloride 600mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1177-2016
Class II · Moderate risk Terminated

Calcium Sodium Edta 300mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1176-2016
Class II · Moderate risk Terminated

B-Complex 50 in Nacl 0.9%

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1172-2016
Class II · Moderate risk Terminated

B-Complex Without B12 W/Pres

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1171-2016
Class II · Moderate risk Terminated

B-Complex Without B12

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1170-2016
Class II · Moderate risk Terminated

B-Complex

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1169-2016
Class II · Moderate risk Terminated

B-Complex #3 W/Pres

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1168-2016
Class II · Moderate risk Terminated

B-Complex #3

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1167-2016
Class II · Moderate risk Terminated

1% Clotrimazol cream

Reason CGMP Deviations

Profarma Distributors LLC D-1043-2016
Class II · Moderate risk Terminated

VERMOX Tablets 500 mg

Reason CGMP Deviations

Profarma Distributors LLC D-1042-2016
Class II · Moderate risk Terminated

VERMOX Tablets 100 mg

Reason CGMP Deviations

Profarma Distributors LLC D-1041-2016
Class II · Moderate risk Terminated

tabcin NOCHE

Reason CGMP Deviations

Profarma Distributors LLC D-1040-2016
Class II · Moderate risk Terminated

tabcin ACTIVE M.R. Capsules

Reason CGMP Deviations

Profarma Distributors LLC D-1039-2016
Class II · Moderate risk Terminated

Tazorac

Reason Failed Content Uniformity Specifications.

Allergan Sales, LLC D-1065-2016
Class II · Moderate risk Terminated

Tazorac

Reason Failed Content Uniformity Specifications.

Allergan Sales, LLC NDC 0023-8335-03 D-1064-2016
Class II · Moderate risk Terminated

Coppertone SUNSCREEN LOTION

Reason Labeling; Product Contains Undeclared API (Oxybenzone)

Bayer Health Care LLC NDC 11523-7391-1 D-0977-2016
Class II · Moderate risk Terminated

Bromocriptine Mesylate Capsules USP

Reason Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.

Zydus Pharmaceuticals USA Inc NDC 68382-110-06 D-1491-2016
Class II · Moderate risk Terminated

8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-310-50 D-1434-2016
Class II · Moderate risk Terminated

6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl

Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Pharmedium Services, LLC NDC 61553-156-86 D-1433-2016