Class III · Low risk
Primidone Tablets
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Rabeprazole Sodium Delayed Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
Affected NDCs
65162-0724-03
65162-0724-09
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Rabeprazole Sodium Rabeprazole NDC 65162-0724 |
SODIUM 20 mg/1 | Tablet, Delayed Release Oral |
Amneal Pharmaceuticals LLC | Rx |
- Recalling firm
- Amneal Pharmaceuticals LLC
- NDC code
- 65162-0724-03
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0693-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Amneal Pharmaceuticals LLC
All 2016 recalls
Class II · Moderate risk
traMADol Hydrochloride Tablets
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Other dissolution failure recalls from 2016
All dissolution failure recalls
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
Class II · Moderate risk
Flucanozole Tablets
Failed Dissolution Specifications; 18 month stability time point
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