FDA Recall D-0767-2022
Jubilant Cadista Pharmaceuticals, Inc. · Salisbury, MD
Class I — life-threatening Terminated 252 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
Reason for recall
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Recall record
- Recall number
D-0767-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
- Recall initiated
- 2022-03-08
- Classified by FDA Center
- 2022-04-12
- FDA published
- 2022-04-06
- Terminated
- 2022-11-15
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Firm location
- Salisbury, MD
Drug identification
- Brand name(s)
- MECLIZINE HYDROCHLORIDE
- Generic name(s)
- MECLIZINE HYDROCLORIDE
- Manufacturer(s)
- Jubilant Cadista Pharmacuticals Inc.
- NDC(s)
59746-121, 59746-122- Route(s)
- ORAL