Why it was recalled
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Product description
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,
Lot numbers, UPCs & expiration codes
Lot #: B1121W, Exp.Date: 04/2022
Where it was sold
recalled product was distributed to three physicians located CA
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-0342-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 12, 2021
- FDA report date
- May 5, 2021
- Quantity
- Six bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0342-2021, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 87719
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: B1121W, Exp.Date: 04/2022
- Postal code
- 92807-1801
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0342-2021
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- Six bottles
- Reason for recall
- Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,
- Distribution pattern
- recalled product was distributed to three physicians located CA
- Recall initiation date
- Apr 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 26, 2021