Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (ND...
FDA Recall #D-0061-2021 — Class II — October 2, 2020
Product Description
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling Firm
Marksans Pharma Limited — Vasco Da Gama, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles
Distribution
Nationwide
Code Information
a) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.