Drug product
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
Product summary
- Event
- Event 88392
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 cases (12 bottles/case)
- Official record key
drug-enforcement:D-0722-2021
Official wording
Reason: Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Code information: Lot: C62F Exp. 31OCT2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
Lack of CGMP