🔍 RecallPedia

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00

Class I - Dangerous
💊 Drugs Recalled: October 11, 2020 RemedyRepack Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021
  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:
RemedyRepack Inc.
Reason for Recall:
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00

Product Codes/Lot Numbers:

Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021

Distribution:

Distributed in: PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0050-2021

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