Cephalexin for Oral Suspension recall: CGMP Deviations
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)…
Why was Cephalexin for Oral Suspension recalled?
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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)…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 103,940 bottles
- Distribution
- Nationwide in the U.S. and Puerto Rico.
- Recall date
- September 16, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)