Recalls / Class I
Class ID-0767-2022
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
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
- 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 # 22P0036, Exp 12/2024
Why it was recalled
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
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmacuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 12,174 bottles
- Distribution pattern
- Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Timeline
- Recall initiated
- 2022-03-08
- FDA classified
- 2022-04-12
- Posted by FDA
- 2022-04-06
- Terminated
- 2022-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0767-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.