Class II · Moderate risk
Oxcarbazepine Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Oxcarbazepine Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
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
Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01
Affected NDC
62584-0143-01
Compare with the code on your package — it is the most precise check available.
Drug: Oxcarbazepine
- Recalling firm
- American Health Packaging
- NDC code
- 62584-143-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1590-2014 · 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 Oxcarbazepine recalls
See all
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Failed Impurities/Degradation Specificattion
Class II · Moderate risk
Oxcarbazepine active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Other recalls by American Health Packaging
All 2014 recalls
Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
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