🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: October 2, 2020 Marksans Pharma Limited Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Marksans Pharma Limited
Reason for Recall:
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0061-2021

Related Recalls

Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count 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 49483-624-01

Marksans Pharma Limited

Class I - Dangerous

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Oct 2, 2020 Prescription Drugs Nationwide View Details →

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, 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 Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01

Marksans Pharma Limited

Class I - Dangerous

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Jun 5, 2020 Prescription Drugs Nationwide View Details →