FDA Recall D-0342-2018
Magno Humphries Laboratories, Inc · Tigard, OR
Class I — life-threatening Terminated 688 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
Reason for recall
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Recall record
- Recall number
D-0342-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-01-17
- Classified by FDA Center
- 2018-02-09
- FDA published
- 2018-02-21
- Terminated
- 2019-12-06
- Recalling firm
- Magno Humphries Laboratories, Inc
- Firm location
- Tigard, OR