January 12, 2018
Warning of the possibility of overly potent tablets, Pfizer Inc. is recalling 100- and 1000-count bottles of diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg. The Class I recall was included in the January 10, 2018, US Food and Drug Administration (FDA) Enforcement Report.
Pfizer voluntarily initiated the recall October 20, 2017. On January 4, 2018, the FDA designated it Class I, indicating use of the prescription diarrhea medication could cause serious health problems or death in patients.
According to the FDA report, weight variations in the tablets have resulted in both subpotent and superpotent drugs. The recall spans a total 183,437 bottles distributed across the United States.
The recall includes:
- 100-count bottles (NDC 59762-1061-1) from lots R83962, R93347, R93348, R93349, R93350, R93351, and R93352 (Exp. 10/31/21), and S57831, S57832, and S57834 (Exp. 11/30/21); and
- 1000-count bottles (NDC 59762-1061-2) from lots R93356, R93357, R93358, and R97310 (Exp. 10/31/21).
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