Recalls / Class I
Class ID-0662-2016
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
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.
- Affected lot / code info
- lot # 45810; Exp. 05/18
Why it was recalled
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Recalling firm
- Firm
- Medline Industries Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Medline Pl, Mundelein, Illinois 60060-4485
Distribution
- Quantity
- 7,372 HDPE Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-09-25
- FDA classified
- 2016-02-12
- Posted by FDA
- 2016-02-24
- Terminated
- 2016-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0662-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.