Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

FDA recall notice · announced August 18, 2021 · Pai Holdings, Llc. Dba Pharmaceutical Associates

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

Reason for recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot: C9BC Exp. 31OCT2022
Quantity: 75 cases (6 bottles/case)
Status: Terminated
Products in this recall event:
- Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08 (D-0722-2021)
- Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmace (D-0721-2021)
- Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16 (D-0723-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.