Why it was recalled
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0589-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 9, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 206,513 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alva-Amco Pharmacal Companies., Inc.
Original FDA data
Every field from FDA enforcement report D-0589-2018, exactly as published.
Show all FDA fields
- City
- Niles
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79450
- Address
- 7711 N Merrimac Ave
- 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
- Postal code
- 60714-3423
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0589-2018
- Classification
- Class III
- Recalling firm
- Alva-Amco Pharmacal Companies., Inc.
- Product quantity
- 206,513 tubes
- Termination date
- Jun 26, 2020
- Reason for recall
- Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria
- Recall initiation date
- Mar 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2018