Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Reported: November 22, 2017 Initiated: October 30, 2017 #D-0082-2018
Product Description
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Reason for Recall
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 744 bottles
- Distribution
- Nationwide
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 744 bottles.
Why was this product recalled? ▼
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 22, 2017. Severity: Low. Recall number: D-0082-2018.
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