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.
Reported: September 16, 2020 Initiated: August 24, 2020 #D-0012-2021
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.
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 103,940 bottles
- Distribution
- Nationwide in the U.S. and Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 103,940 bottles.
Why was this product recalled? ▼
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 16, 2020. Severity: Moderate. Recall number: D-0012-2021.
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