🔍 RecallPedia

ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732

Class I - Dangerous
💊 Drugs Recalled: April 3, 2017 Medisca Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    a) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F
  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:
Medisca, Inc.
Reason for Recall:
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732

Product Codes/Lot Numbers:

a) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0663-2017

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