Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Reported: February 1, 2017 Initiated: December 21, 2016 #D-0440-2017
Product Description
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Reason for Recall
Subpotency: due to a low, out of specification test result for assay during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 133,601 bottles
- Distribution
- United States 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 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73. Recalled by Teva Pharmaceuticals USA. Units affected: 133,601 bottles.
Why was this product recalled? ▼
Subpotency: due to a low, out of specification test result for assay during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2017. Severity: Moderate. Recall number: D-0440-2017.
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