Teva Recalls Amoxicillin Oral Suspension Due to Discoloration on Foil Seal
Teva Pharmaceuticals is recalling specific lots of Amoxicillin for Oral Suspension because of orange to brown discoloration found on the inner foil seal.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries or illnesses.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 109,080 bottles of Amoxicillin for Oral Suspension, USP 200 mg/5 mL. The affected products are available in 75 mL and 100 mL bottles and were distributed nationwide. The recall involves specific lot numbers with an expiration date of 08/14.
The recall is being conducted due to an orange to brown discolored Amoxicillin powder observed on the inner foil seal of the bottles. This action is an expansion of a previous recall identified as RES 65050.
Consumers who have these specific bottles should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 109,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #s: a) 35426557A
- 35426558A
- Exp 08/14
- b) 35426554A
- 35426555A
- 35426556A
UPCs (9)
- 0300933107051
- 0300932264014
- 0300934161731
- 0300933109055
- 0300932267015
- 0300932268012
- 0300932263017
- 0300934160734
- 0300934155730
Distribution
Distributed nationwide across the United States.
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