Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Meclizine Hydrochloride Tablets USP (Meclizine Hydrocloride)
Class I — High risk. Reasonable probability of serious harm or death.
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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What 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
Affected NDC
59746-0122-06
Compare with the code on your package — it is the most precise check available.
Drug: Meclizine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Meclizine Hydrochloride NDC 59746-0122 |
12.5 mg/1 | Tablet Oral |
Jubilant Cadista Pharmacuticals Inc. | Rx |
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- NDC code
- 59746-122-06
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0767-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Meclizine recalls
See all
Class II · Moderate risk
Meclizine Hydrochloride Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Other recalls by Jubilant Cadista Pharmaceuticals, Inc.
All 2022 recalls
Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
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