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
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 22P0036, Exp 12/2024
Where it was sold
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0767-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 8, 2022
- FDA report date
- Apr 6, 2022
- Quantity
- 12,174 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0767-2022, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 89854
- Address
- 207 Kiley Dr
- Code information
- Lot # 22P0036, Exp 12/2024
- Postal code
- 21801-2249
- Report date
- Apr 6, 2022
- Product type
- Drugs
- Recall number
- D-0767-2022
- Classification
- Class I
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 12,174 bottles
- Termination date
- Nov 15, 2022
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
- Recall initiation date
- Mar 8, 2022
- Initial firm notification
- Center classification date
- Apr 12, 2022