TG United Recalls CPM PSE Drops Due to CGMP Deviations
TG United, Inc. is recalling CPM / PSE Drops because the products are underdosed or have an incorrect dosage regime.
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: The recall is classified as FDA Class II and involves a CGMP deviation (underdosing) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
TG United, Inc. is recalling 6,551 bottles of CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. The recalled product is manufactured for Trigen Laboratories and carries NDC 13811-071-30. The specific lot affected is Lot# 11GQ003 with an expiration date of 06/13.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products are underdosed or have an incorrect dosage regime. The affected units were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Nasal Decongestant
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# 11GQ003 Exp 06/13.
Distribution
Part of a larger recall action
This product is one of 44 recalled by TG United, 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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