🔍 RecallPedia

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Class I - Dangerous
💊 Drugs Recalled: January 14, 2020 Spectrum Laboratory Products Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot #:11E0585, Exp. October 2023
  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:
Spectrum Laboratory Products
Reason for Recall:
CGMP Deviations: Presence of NDMA impurity detected in product.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Product Codes/Lot Numbers:

Lot #:11E0585, Exp. October 2023

Distribution:

Distributed in: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0825-2020

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