Recalls / Class III
Class IIID-1516-201
Product
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
- Brand name
- Escitalopram
- Generic name
- Escitslopram
- Active ingredient
- Escitalopram Oxalate
- Route
- Oral
- NDCs
- 68180-137, 68180-135, 68180-136
- FDA application
- ANDA078169
- Affected lot / code info
- Lot # G510086; Exp. 11/17
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Expiration Date
Recalling firm
- Firm
- Lupin Limited
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 15-B, Phase 1A, Verna Industrial Area, Verna, Salcette, Goa, N/A, India
Distribution
- Quantity
- 3,192 bottles (319,200 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-24
- FDA classified
- 2016-09-21
- Posted by FDA
- 2016-09-28
- Terminated
- 2017-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1516-201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.