Recalls / Class III
Class IIID-0096-2022
Product
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
- Brand name
- Cetirizine
- Generic name
- Cetirizine Hydrochloride
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDC
- 50090-5510
- FDA application
- ANDA078336
- Affected lot / code info
- Lot #: 1256330
Why it was recalled
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Recalling firm
- Firm
- A-S Medication Solutions LLC.
- Manufacturer
- A-S Medication Solutions
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2401 Commerce Dr, N/A, Libertyville, Illinois 60048-4464
Distribution
- Quantity
- 72 bottles
- Distribution pattern
- FL, IN, MN, WI
Timeline
- Recall initiated
- 2021-10-05
- FDA classified
- 2021-11-05
- Posted by FDA
- 2021-11-17
- Terminated
- 2022-08-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.