Why it was recalled
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Product description
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Lot numbers, UPCs & expiration codes
100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16
Where it was sold
Nationwide
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-1239-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 29, 2015
- FDA report date
- Jul 22, 2015
- Quantity
- 47,376 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1239-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 71646
- Address
- 120 Vintage Dr NE
- Code information
- 100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16
- Postal code
- 35811-8216
- Report date
- Jul 22, 2015
- Product type
- Drugs
- Recall number
- D-1239-2015
- Classification
- Class III
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 47,376 bottles
- Termination date
- Oct 23, 2016
- Reason for recall
- Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 29, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2015