Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Reported: August 19, 2020 Initiated: August 4, 2020 #D-1494-2020
Product Description
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Reason for Recall
Subpotent drug: Out of specification for assay at the 15-month test interval.
Details
- Recalling Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Units Affected
- 7416 bottles
- Distribution
- Nationwide USA
- 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, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16. Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc. Units affected: 7416 bottles.
Why was this product recalled? ▼
Subpotent drug: Out of specification for assay at the 15-month test interval.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 19, 2020. Severity: Moderate. Recall number: D-1494-2020.
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