AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Reported: January 3, 2024 Initiated: January 26, 2022 #D-0165-2024
Product Description
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Details
- Recalling Firm
- CARDINAL HEALTHCARE
- Units Affected
- 3 units
- Distribution
- Nationwide USA
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73. Recalled by CARDINAL HEALTHCARE. Units affected: 3 units.
Why was this product recalled? ▼
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0165-2024.
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