Drug product
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00.
D-0486-2015
Product summary
- Event
- Event 70987
- Status
- Terminated
- Classification
- Class III
- Quantity
- 78,522 Cartons
- Official record key
drug-enforcement:D-0486-2015
Official wording
Reason: Subpotent Drug: Flurandrenolide is subpotent.
Code information: A) Lots: 266142A, 843021, 845760, 853846, 893193, 900634; Expiry: JAN-2016. B) Lots: 266142D, 822241, 853847, 862000, 874337, 893209; Expiry: JAN-2016. C) Lot: 266142C; Expiry: JAN-2016.
Distribution pattern: U.S. Nationwide, including Puerto Rico; United Kingdom.
Derived failure modes
-
Potency or specification failure
Subpotent