Reported Jul 22, 2015 · Terminated
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and…
Qualitest Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216
Is this the product you have?
- 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 codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 100 count (NDC 0603-3968-21) 2 LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16 3 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15 4 and 1000 count (NDC 0603-3968-32) 5 LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16 - Amount recalled
- 47,376 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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