Novel Laboratories, Inc.

FDA Regulatory Profile

Novel Laboratories, Inc. appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0599-2018, Class III) was initiated on March 5, 2018.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0599-2018Class IIILupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets March 5, 2018
D-0653-2017Class IIIFluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 February 22, 2017
D-1484-2014Class IIIFamotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for InjectJune 20, 2014