Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Reported: February 5, 2020 Initiated: January 14, 2020 #D-0824-2020
Product Description
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Reason for Recall
Subpotent: Out of specification for assay at the 12-month time point.
Details
- Recalling Firm
- Pharmaceutical Associates Inc
- Units Affected
- 6288 16 oz bottles
- Distribution
- Distributed Nationwide in the US
- Location
- Greenville, SC
Frequently Asked Questions
What product was recalled? ▼
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16. Recalled by Pharmaceutical Associates Inc. Units affected: 6288 16 oz bottles.
Why was this product recalled? ▼
Subpotent: Out of specification for assay at the 12-month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2020. Severity: Moderate. Recall number: D-0824-2020.
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