Recalls / Class III
Class IIID-803-2013
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.
- Brand name
- Amoxicillin
- Generic name
- Amoxicillin
- Active ingredient
- Amoxicillin
- Route
- Oral
- NDCs
- 0093-2263, 0093-2264, 0093-4160, 0093-4155, 0093-4161, 0093-2267, 0093-2268, 0093-3107, 0093-3109
- FDA application
- ANDA065056
- Affected lot / code info
- Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
Why it was recalled
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 109,080 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-06-18
- FDA classified
- 2013-07-17
- Posted by FDA
- 2013-07-24
- Terminated
- 2013-12-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-803-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.