PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 18, 2021 Initiated: July 29, 2021 #D-0722-2021

Product Description

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

Reason for Recall

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

Details

Units Affected
400 cases (12 bottles/case)
Distribution
Distributed Nationwide in the USA
Location
Greenville, SC

Frequently Asked Questions

What product was recalled?
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. Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc. Units affected: 400 cases (12 bottles/case).
Why was this product recalled?
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 18, 2021. Severity: Moderate. Recall number: D-0722-2021.