Recalls / Class II
Class IID-1695-2012
Product
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
- Brand name
- Synthroid
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 0074-3727, 0074-4341, 0074-4552, 0074-5182, 0074-6594, 0074-6624, 0074-9296, 0074-7068, 0074-7069, 0074-7070 +2 more
- FDA application
- NDA021402
- Affected lot / code info
- Lot: 18353A8, Exp 08/31/2013
Why it was recalled
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Recalling firm
- Firm
- Abbott Laboratories
- Manufacturer
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Abbott Park Rd, N/A, Abbott Park, Illinois 60064-3502
Distribution
- Quantity
- 42,596 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-19
- FDA classified
- 2012-09-26
- Posted by FDA
- 2012-10-03
- Terminated
- 2013-11-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1695-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.