Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Hydrocodone bitartrate and acetaminophen Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
Affected NDCs
0603-3888-02
0603-3888-04
0603-3888-16
0603-3888-20
0603-3888-21
0603-3888-22
0603-3888-26
0603-3888-28
0603-3888-32
Compare with the code on your package — it is the most precise check available.
Drug: Acetaminophen Category: Pain Relief & OTC Medication
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- NDC code
- 0603-3888-16
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-138-2013 · 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 Acetaminophen recalls
See all
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Tylenol
Defective Container
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Other recalls by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
All 2012 recalls
Class III · Low risk
Hydrocortisone Lotion
Superpotent Drug: above specification for the assay.
Class III · Low risk
Dexamethasone Elixir
Failed Impurities/ Degradation Specifications
Class III · Low risk
Temazepam Capsules USP
Failed Stability Specifications
Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
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