TOLMAR, Inc.

FDA Regulatory Profile

TOLMAR, Inc. appears in FDA public data with 4 recalls, 0 510(k) clearances, 16 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1178-2023, Class III) was initiated on September 12, 2023.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
16
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1178-2023Class IIIEligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must bSeptember 12, 2023
D-1300-2022Class IINaftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48July 11, 2022
D-0282-2022Class IIClindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO November 8, 2021
D-66402-001Class IIIKetoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, September 23, 2013