CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
Reported: June 12, 2013 Initiated: January 30, 2013 #D-534-2013
Product Description
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Details
- Recalling Firm
- TG United, Inc.
- Units Affected
- 26,315 - 30 mL bottles.
- Distribution
- FL, MS, SC, LA and TX
- Location
- Brooksville, FL
Frequently Asked Questions
What product was recalled? ▼
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30. Recalled by TG United, Inc.. Units affected: 26,315 - 30 mL bottles..
Why was this product recalled? ▼
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-534-2013.
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