Why it was recalled
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Product description
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Lot numbers, UPCs & expiration codes
Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.
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-0012-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2020
- FDA report date
- Sep 16, 2020
- Quantity
- 103,940 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0012-2021, 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 #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.
- Postal code
- 07054-1120
- Report date
- Sep 16, 2020
- Product type
- Drugs
- Recall number
- D-0012-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 103,940 bottles
- Termination date
- Dec 16, 2021
- Reason for recall
- CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- 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