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Recall Observatory FDA recall evidence

Drug product

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

D-1426-2014

September 19, 2013

Class III

Product summary

Firm
Ferring Pharmaceuticals Inc
Event
Event 66604
Status
Terminated
Classification
Class III
Quantity
72,046 cartons
Official record key
drug-enforcement:D-1426-2014

Official wording

Reason: Discoloration; due to prolonged heat exposure.

Code information: Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration; due to prolonged heat exposure.