Qualitest Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurity
Vintage Pharmaceuticals is recalling 73,746 bottles of Hydroxyzine Hydrochloride Oral Solution because high levels of a known impurity were detected.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where use of the product is not likely to cause adverse health consequences.
Plain-English summary
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals is recalling 73,746 bottles of Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 1 pint (473 mL). The recall is due to high out-of-specification results for a known impurity found at the 12-month room temperature time point.
The affected product is distributed nationwide. The specific lot numbers and expiration dates involved are: L030F11A and L054F11A (Exp 05/13); L095E10A (Exp 06/13); L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, and L088K11A (Exp 10/13); L094L10A (Exp 12/13); and L100L10B (Exp 01/14).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 73,746
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lot #s: L030F11A
- L054F11A
- Exp 05/13
- L095E10A
- Exp 06/13
- L079J10A
- L085K11A
- L086K11A
- L087G10A
- L087K11A
- L088K11A
- Exp 10/13
- L094L10A
- Exp 12/13
- and L100L10B
- Exp 01/14
Distribution
Distributed nationwide across the United States.
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