Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported January 8, 2014
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Qualitest Pharmaceuticals recalled Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120… - a low-severity action.
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120… was recalled by Qualitest Pharmaceuticals in January 8, 2014. Reason: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenon…. Check the official notice for the remedy. Verify recall #D-394-2014 with the FDA Drug before acting.
The recall
Qualitest Pharmaceuticals issued this low-severity FDA Drug recall-Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenon….
- Low
- severity level
- Class III
- classification
- January 8, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-394-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-394-2014) was formally reported on January 8, 2014, with the manufacturer initiating the action on December 16, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Qualitest Pharmaceuticals is listed as the recalling firm, operating out of Huntsville, AL. Federal records list the affected scope as 438,055 bottles.
The documented reason for this recall is: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
438,055 bottles
Related Recalls
6
5 from same agency
Product description
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Reason for recall
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-394-2014 |
| Date reported | January 8, 2014 |
| Date initiated | December 16, 2013 |
| Recalling firm | Qualitest Pharmaceuticals |
| Firm location | Huntsville, AL |
| Affected scope | 438,055 bottles |
| Distribution | Nationwide and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-394-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).. Recalled by Qualitest Pharmaceuticals. Units affected: 438,055 bottles.
Why was this product recalled? ▼
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2014. Severity: Low. Recall number: D-394-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-394-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 8, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.