Recalls / Class I
Class ID-0150-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
- Brand name
- Diphenoxylate Hydrochloride And Atropine Sulfate
- Generic name
- Diphenoxylate Hydrochloride And Atropine Sulfate
- Active ingredients
- Atropine Sulfate, Diphenoxylate Hydrochloride
- Route
- Oral
- NDC
- 59762-1061
- FDA application
- NDA012462
- Affected lot / code info
- Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31.
Why it was recalled
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 183437 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-20
- FDA classified
- 2018-01-04
- Posted by FDA
- 2018-01-10
- Terminated
- 2020-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0150-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.