This is a class II recall, the most common type of recall, which means that there is a situation where the use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recalls a particular medication. In this case, the manufacturer has voluntarily recalled diphenoxylate/atropine.
Why were these products recalled?
Greenstone LLC has issued a recall due to possible sub-potent and super-potent tablets. In other words, some tablets may contain too much medication (super potent) or not enough medication (sub-potent).
Taking a diphenoxylate/atropine tablet that contains too much medication can cause life-threatening toxicity, coma, problems breathing, lethargy, skin flushing, and drowsiness. On the other hand, taking a diphenoxylate/atropine tablet that doesn’t contain enough medication can worsen diarrhea.
Have there been any adverse events reported to the FDA from patients?
No. At this time, the FDA has not received any reports of adverse events associated with this recall.
Which products were recalled?
According to the FDA’s announcement, the affected products were distributed nationwide to wholesalers and retailers in the United States from November 2016 to June 2017.
This recall will affect the following:
- Drug: Diphenoxylate/atropine 2.5 mg/0.025 mg tablets
- Manufacturer: Greenstone, LLC
- Bottle Size: 100-count (NDC 59762-1061-01), 1000 count (NDC 59762-1061-02)
- 100-count bottles: R83962, R93347, R93348, R93349, R93350, R93351, R93352, S57831, S57832, S57834
- 1000-count bottles: R93356, R93357, R93358, R97310
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