Recalls / Class III
Class IIID-1426-2014
Product
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
- Brand name
- Endometrin
- Generic name
- Progesterone
- Active ingredient
- Progesterone
- Route
- Vaginal
- NDC
- 55566-6500
- FDA application
- NDA022057
- Affected lot / code info
- 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
Why it was recalled
Discoloration; due to prolonged heat exposure.
Recalling firm
- Firm
- Ferring Pharmaceuticals Inc
- Manufacturer
- Ferring Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4 Gatehall Dr Fl 3rd, Parsippany, New Jersey 07054-4518
Distribution
- Quantity
- 72,046 cartons
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2013-09-19
- FDA classified
- 2014-07-09
- Posted by FDA
- 2014-07-16
- Terminated
- 2015-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1426-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.