Ointment Recalled Over Splitting Tubes

Defective containers have prompted Glenmark Pharmaceuticals Inc to recall 654,756 tubes of tacrolimus ointment 0.1%. According to the August 10, 2022, US Food and Drug Administration (FDA) Enforcement Report, tubes containing the ointment may split at the side seam.

The recall affects the following products, which were manufactured in India for Glenmark Pharmaceuticals Inc, Mahwah, NJ, and distributed throughout the United States:

• tacrolimus ointment 0.1%, 30 g tube (NDC 68462-534-35), from lots 15200058, 15200066, and 15200067 (Exp. 6/22); 15200075 (Exp. 7/22); 15200094 (Exp. 8/22); 15200119, 15200120, and 15200122 (Exp. 9/22); 15200131 and 15200132 (Exp. 10/22); 15200133, 15200134, 15200136, and 15200139 (Exp. 11/22); 15210033, 15210035, 15210036, and 15210038 (Exp. 1/23); 15210092, 15210094, 15210097, and 15210099 (Exp. 3/23); 15210100, 15210101, and 15210104 (Exp. 4/23); 15210122 (Exp. 5/23); 15210148, 15210149, 15210153, 15210155, 15210157, and 15210158 (Exp. 6/23); 15210173, 15210174, 15210176, 15210177, 15210178, and 15210179 (Exp. 7/23); 15210184 and 15210186 (Exp. 8/23); 15210214 (Exp. 9/23); 15210225, 15210226, 15210228, 15210230, and 15210231 (Exp. 10/23); and 15220001 and 15220002 (Exp. 12/23);
• tacrolimus ointment 0.1%, 60 g tube (NDC 68462-534-65), from lots 15200092 (Exp. 8/22); 15200114 and 15200115 (Exp. 9/22); 15200123 and 15200124 (Exp. 10/22); 15200142 and 15200144 (Exp. 11/22); 15210014, 15210015, and 15210021 (Exp. 12/22); 15210031 (Exp. 1/23); 15210055 (Exp. 2/23); 15210073 and 15210075 (Exp. 3/23); 15210117 and 15210118 (Exp. 4/23); 15210144, 15210147, 15210160, and 15210162 (Exp. 6/23); 15210171 (Exp. 7/23); 15210187, 15210190, 15210191, and 15210193 (Exp. 8/23); 15210212 (Exp. 9/23); 15210244 and 15210247 (Exp. 11/23); 15220007 (Exp. 12/23); 15220019 and 15220028 (Exp. 1/24); 15220032, 15220034, and 15220053 (Exp. 2/24); and 15220062, 15220064, and 15220072 (Exp. 3/24); and
• tacrolimus ointment 0.1%, 100 g tube (NDC 68462-534-94), from lots 15200065 (Exp. 6/22); 15200108 and 15200109 (Exp. 9/22); 15200125 (Exp. 10/22); 15200148, 15200149, and 15200150 (Exp. 11/22); 15210007, 15210009, 15210012, and 15210018 (Exp. 12/22); 15210049 (Exp. 2/23); 15210076, 15210077, and 15210089 (Exp. 3/23); 15210112 and 15210114 (Exp. 4/23); 15210124, 15210125, and 15210127 (Exp. 5/23); 15210169 and 15210170 (Exp. 7/23); 15210196 and 15210199 (Exp. 8/23); 15210204, 15210206, 15210207, and 15210210 (Exp. 9/23); 15210248 (Exp. 11/23); 15220004, 15220013, 15220014, and 15220015 (Exp. 12/23); and 15220025 and 15220026 (Exp. 1/24).

Glenmark Pharmaceuticals voluntarily initiated the recall July 11, 2022. On August 4, 2022, the FDA designated the recall Class III. Under the recall classification, use of the recalled ointment is not likely to cause harm.

Tacrolimus ointment a prescription topical medication used to treat atopic dermatitis.