D-1441-2014 Class III Terminated
FDA drug recall D-1441-2014 was initiated by Fougera Pharmaceuticals Inc. on July 3, 2014 and is designated Class III. Reason for recall: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. The recall status is terminated (terminated December 7, 2015). Affected quantity: 3,594 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 23, 2014
- Initiation Date
- July 3, 2014
- Termination Date
- December 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,594 Bottles
Product Description
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
Reason for Recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Distribution Pattern
Nationwide
Code Information
Lot: 849R, Exp 04/2015