Why it was recalled
Labeling: Incorrect or Missing Lot and/or Expiration date.
Product description
Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.
Lot numbers, UPCs & expiration codes
Lot #s: a) P138855, Exp. 05/30/2022; b) P138856, Exp. 05/30/2022
Where it was sold
Ohio
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-0868-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 14, 2020
- FDA report date
- Mar 11, 2020
- Quantity
- 3456 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AAA Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0868-2020, exactly as published.
Show all FDA fields
- City
- Lumberton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84938
- Address
- 681 Main St
- Code information
- Lot #s: a) P138855, Exp. 05/30/2022; b) P138856, Exp. 05/30/2022
- Postal code
- 08048-5013
- Report date
- Mar 11, 2020
- Product type
- Drugs
- Recall number
- D-0868-2020
- Classification
- Class III
- Recalling firm
- AAA Pharmaceutical, Inc.
- Product quantity
- 3456 Bottles
- Termination date
- May 5, 2023
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Expiration date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.
- Distribution pattern
- Ohio
- Recall initiation date
- Feb 14, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 4, 2020