Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Reported: January 25, 2017 Initiated: December 13, 2016 #D-0435-2017
Product Description
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Reason for Recall
Subpotent Drug: out of specification results for assay test.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- a) 10,200 bottles; b) 300 bottles
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.. Recalled by Sandoz Inc. Units affected: a) 10,200 bottles; b) 300 bottles.
Why was this product recalled? ▼
Subpotent Drug: out of specification results for assay test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2017. Severity: Low. Recall number: D-0435-2017.
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