CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Double Tussin DM (Dextromethorphan Hbr 20 mg recalled by Pharma-Natural
Pharma-Natural is recalling Double Tussin DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each teaspoon, distributed nationwide in the US. The recall was initiated on 21 Jun 2019 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-1498-2019
- FDA event ID
- 83190
- Recalling firm
- Pharma-Natural, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cold & Cough Medicine
Timeline
| 21 Jun 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +32 days |
| 31 Jul 2019 | 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 were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Where it was distributed
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Questions about this recall
Is Double Tussin DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each teaspoon recalled?
Yes. Pharma-Natural recalled Double Tussin DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each teaspoon on 21 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1498-2019.
Why was it recalled?
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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