Drug product
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
D-803-2013
Product summary
- Event
- Event 65516
- Status
- Terminated
- Classification
- Class III
- Quantity
- 109,080 Bottles
- Official record key
drug-enforcement:D-803-2013
Official wording
Reason: Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Code information: Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.