TG United Recalls CPM PSE DM Drops Due to Underdosing
TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or structural defects, though here it reflects the agency's classification of a dosage error.
Plain-English summary
TG United, Inc. is recalling 26,315 bottles of CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. The product is manufactured for Trigen Laboratories, Sayreville, NJ, and is identified by NDC 13811-072-30.
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 lots are Lot# 11EQ007 (Exp 04/13) and Lot# 12BQ001 (Exp 01/14). These products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers who have these products should stop using them and contact TG United, Inc. for further instructions.
The recalled product
- Product
- CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
- Manufacturer
- TG United, Inc.
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 (2)
- Lot# 11EQ007 Exp 04/13
- Lot# 12BQ001 Exp. 01/14..
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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