Why it was recalled
Sub-Potent Drug: Out of specification test results for potency (below specification).
Product description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
Lot numbers, UPCs & expiration codes
Lot #: 30310638A, Exp. 02/2022
Where it was sold
Nationwide in the U.S. and Puerto Rico.
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-1566-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2020
- FDA report date
- Sep 16, 2020
- Quantity
- 38,487 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1566-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86285
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 30310638A, Exp. 02/2022
- Postal code
- 07054-1120
- Report date
- Sep 16, 2020
- Product type
- Drugs
- Recall number
- D-1566-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 38,487 bottles
- Termination date
- Dec 16, 2021
- Reason for recall
- Sub-Potent Drug: Out of specification test results for potency (below specification).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico.
- Recall initiation date
- Aug 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 2, 2020