CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant recalled
TG United is recalling AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla, distributed in Florida, Louisiana, Mississippi, South Carolina, Texas. The recall was initiated on 30 Jan 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-511-2013
- FDA event ID
- 64188
- Recalling firm
- TG United, Brooksville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jan 2013
- FDA classified
- 4 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Nasal Sprays
Timeline
| 30 Jan 2013 | Recall initiated by company | |
| 4 Jun 2013 | Classified by FDA | +125 days |
| 12 Jun 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product as listed by the FDA
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
Where it was distributed
FL, MS, SC, LA and TX
Questions about this recall
Why was it recalled?
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Which lots are affected?
Lot # 12HQ004, Exp. 07/14.
Where was it sold?
FL, MS, SC, LA and TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
43 other products · FDA event 64188This product is part of a recall event; the main page for the event is AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant recalled.
More recalls from TG United
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|---|---|---|---|---|---|
| Drug | CLASS II | Cardec Drops,Antihistamine, Nasal Decongestant recalled by TG United | TG United | Manufacturing (CGMP) Deviations | 5 states |
| Drug | CLASS II | TL Hist DM, Antihistamine, Decongestant, Cough Suppressant recalled | TG United | Manufacturing (CGMP) Deviations | 5 states |
| Drug | CLASS II | Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant recalled | TG United | Manufacturing (CGMP) Deviations | 5 states |
| Drug | CLASS II | NoHist Tablets, Antihistamine, Nasal Decongestant recalled by TG United | TG United | Manufacturing (CGMP) Deviations | 5 states |
| Drug | CLASS II | TG 40PSE/400GFN Tablets recalled by TG United | TG United | Manufacturing (CGMP) Deviations | 5 states |