Status
Terminated
Drug Enforcement D-598-2013
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Classification
Class III
Report Date
June 19, 2013
Termination Date
December 24, 2013
Product Information
- Product description
- Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-598-2013
- Event ID
- 65050
- Recall initiation date
- April 26, 2013
- Center classification date
- June 11, 2013
- 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.
- More code info
- —