Reported Sep 16, 2020 · Terminated
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Lot codes and dates
76 of 76 codes
Lot #s: a) 30309862A30309863AExp. 08/202030309928A30309929AExp. 09/202030310029A30310030A30310033A30310034AExp. 10/202030310035A30310079A30310080A30310081AExp. 11/202030310134A30310135AExp. 01/202130310182A30310183A30310210AExp. 02/202130310211A30310246AExp. 03/202130310282AExp. 04/202130310290AExp. 05/202130310394A30310395AExp.07/202130310457AExp. 09/202130310506A30310507AExp. 10/202130310555A30310605AExp. 11/2021. b) 30309864A30309865AExp. 08/202030309930A30309931AExp. 09/202030309991A30309992A30310028AExp.10/202030310036A30310037A30310038AExp. 11/202030310082A30310083AExp. 12/202030310136A30310137AExp. 01/2021
- Amount recalled
- 1,467,535 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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