🔍 RecallPedia

Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00

Class I - Dangerous
💊 Drugs Recalled: January 26, 2022 ULTRAtab Laboratories Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043
  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:
ULTRAtab Laboratories, Inc.
Reason for Recall:
CGMP Deviations
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00

Product Codes/Lot Numbers:

Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0546-2022

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