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
Reported: April 6, 2022 Initiated: March 8, 2022 #D-0767-2022
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
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
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 12,174 bottles
- Distribution
- Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 12,174 bottles.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 6, 2022. Severity: Critical. Recall number: D-0767-2022.
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