Class III
Terminated
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
- Company
- Teva Pharmaceuticals Usa, Inc.
- Recall Initiated
- April 26, 2013
- Posted
- June 19, 2013
- Recall Number
- D-598-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 758,554 bottles
- Firm Location
- Sellersville, PA, United States
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.
Distribution
Nationwide
Lot / 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.
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