Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation
Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing practice violation (CGMP deficiency) with potential product contamination. No illnesses or injuries have been reported in the source text, and the hazard is theoretical rather than confirmed, which places it at the Moderate level.
Plain-English summary
Pharmaceutical Associates Inc. (PAI Holdings, LLC) is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) bottles nationwide in the United States. The recall involves Lot C62F with an expiration date of October 31, 2022, and applies to approximately 400 cases (12 bottles per case) that were distributed nationwide.
The recall was initiated due to a lack of Current Good Manufacturing Practice (CGMP) compliance, specifically due to the potential for carryover of Senna Syrup into the Cimetidine Hydrochloride Oral Solution product. This manufacturing deficiency poses a risk that the product may not meet established quality and purity standards.
Consumers who have this product should stop using it and consult their healthcare provider or pharmacist for guidance on obtaining an alternative medication.
The recalled product
- 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: C62F Exp. 31OCT2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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