Drug product
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
D-0589-2018
Product summary
- Event
- Event 79450
- Status
- Terminated
- Classification
- Class III
- Quantity
- 206,513 tubes
- Official record key
drug-enforcement:D-0589-2018
Official wording
Reason: Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Code information: Lot #: 61031, 61041, 61051, Exp. 4/30/2018; 61601, 61651, 61751, Exp. 6/30/2018; 61941, Exp. 7/31/2018; 62321, Exp. 8/31/2018; 62561, 62721, Exp. 9/30/2018; 62871, Exp. 10/31/2018; 63331, Exp. 11/30/2018; 72011, 72021, 72131, 72141, Exp. 7/31/2019; 72221, 72441, Exp. 8/31/2019; 72921, Exp. 10/31/2019; 73351, Exp. 11/30/2019
Distribution pattern: Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria
Derived failure modes
-
Potency or specification failure
Subpotent