Recalls / Class III
Class IIID-1239-2015
Product
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
- Affected lot / code info
- 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
Why it was recalled
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 47,376 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-29
- FDA classified
- 2015-07-15
- Posted by FDA
- 2015-07-22
- Terminated
- 2016-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1239-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.