Recalls / Class III
Class IIID-0082-2018
Product
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
- Brand name
- Meclizine Hydrochloride
- Generic name
- Meclizine Hydrocloride
- Active ingredient
- Meclizine Hydrochloride
- Route
- Oral
- NDCs
- 59746-121, 59746-122
- FDA application
- ANDA040659
- Affected lot / code info
- Lot # 17P0430, Exp 05/19
Why it was recalled
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmacuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 744 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-10-30
- FDA classified
- 2017-11-16
- Posted by FDA
- 2017-11-22
- Terminated
- 2020-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0082-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.