Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
Lot numbers, UPCs & expiration codes
Lot #: G0219K, Exp 3/2021; C1419E, Exp 3/2021
Where it was sold
Product was distributed to 1 physician in Gainesville Florida.
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-1877-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 29, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 79 (90 ct.) bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1877-2019, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83711
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: G0219K, Exp 3/2021; C1419E, Exp 3/2021
- Postal code
- 92807-1801
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-1877-2019
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Product quantity
- 79 (90 ct.) bottles
- Termination date
- Apr 24, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
- Distribution pattern
- Product was distributed to 1 physician in Gainesville Florida.
- Recall initiation date
- Aug 29, 2019
- Initial firm notification
- Telephone
- Center classification date
- Sep 24, 2019