Product Detail

Product Description Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

Recall Number D-598-2013

Classification Class III

Code Info a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.

Product Distributed Qty 758,554 bottles

Reason For Recall Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

Event Detail

Event Id 65050

Product Type Drugs

Status Ongoing

Recalling Firm
Teva Pharmaceuticals USA, Inc.
City Sellersville

State PA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-26

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide