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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 1256330
Where it was sold
FL, IN, MN, WI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0096-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 5, 2021
- FDA report date
- Nov 17, 2021
- Quantity
- 72 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A-S Medication Solutions LLC.
Original FDA data
Every field from FDA enforcement report D-0096-2022, exactly as published.
Show all FDA fields
- City
- Libertyville
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88853
- Address
- 2401 Commerce Dr
- Code information
- Lot #: 1256330
- Postal code
- 60048-4464
- Report date
- Nov 17, 2021
- Product type
- Drugs
- Recall number
- D-0096-2022
- Classification
- Class III
- Recalling firm
- A-S Medication Solutions LLC.
- Product quantity
- 72 bottles
- Termination date
- Aug 12, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- FL, IN, MN, WI
- Recall initiation date
- Oct 5, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 5, 2021