Why it was recalled
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Product description
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
Lot numbers, UPCs & expiration codes
Batch/Lot 619442, exp. 01/2015
Where it was sold
Nationwide and Puerto Rico
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-888-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 25, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 58,812 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
Original FDA data
Every field from FDA enforcement report D-888-2013, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65803
- Address
- 369 Bayview Ave
- Code information
- Batch/Lot 619442, exp. 01/2015
- Postal code
- 11701-2801
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-888-2013
- Classification
- Class III
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Product quantity
- 58,812 tubes
- Termination date
- May 16, 2016
- Reason for recall
- Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 25, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2013