Class II · Moderate risk
Aripiprazole Tablets USP
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Aripiprazole Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Affected NDC
31722-0827-30
Compare with the code on your package — it is the most precise check available.
Drug: Aripiprazole
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 |
|---|---|---|---|---|
| Aripiprazole NDC 31722-0827 |
10 mg/1 | Tablet Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- NDC code
- 31722-827-30
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0594-2018 · 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 Aripiprazole recalls
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Other recalls by Hetero Labs, Ltd. - Unit III
All 2018 recalls
Class III · Low risk
Fenofibrate Tablets
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Class II · Moderate risk
Indomethacin Capsules
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class II · Moderate risk
Levetiracetam Oral Solution
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