Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Reported: April 24, 2019 Initiated: April 12, 2019 #D-1205-2019
Product Description
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Reason for Recall
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 171,488 150 mL and 80 mL bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.. Recalled by Teva Pharmaceuticals USA. Units affected: 171,488 150 mL and 80 mL bottles.
Why was this product recalled? ▼
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2019. Severity: Moderate. Recall number: D-1205-2019.
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