Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Reported: April 1, 2020 Initiated: March 19, 2020 #D-1060-2020
Product Description
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Reason for Recall
SubPotent Drug: Low out-of-specification results for assay testing.
Details
- Recalling Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Units Affected
- 7416 bottles
- Distribution
- Nationwide in the 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) bottle, Rx ONLY, pai 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: Low out-of-specification results for assay testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2020. Severity: Moderate. Recall number: D-1060-2020.
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