Drug recall D-598-2013
Product
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
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.
Lots and codes
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.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc., Sellersville, PA
- Quantity
- 758,554 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 26, 2013
- Terminated
- December 24, 2013
Related products
- Amoxicillin – drug information
- NDC 0093-2264 Amoxicillin · Amoxicillin 875 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-2267 Amoxicillin · Amoxicillin 125 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4155 Amoxicillin · Amoxicillin 250 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3107 Amoxicillin · Amoxicillin 250 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4160 Amoxicillin · Amoxicillin 200 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-2263 Amoxicillin · Amoxicillin 500 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-2268 Amoxicillin · Amoxicillin 250 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4161 Amoxicillin · Amoxicillin 400 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3109 Amoxicillin · Amoxicillin 500 mg/1 · Teva Pharmaceuticals USA, Inc.