Class II · Moderate risk
ZoDen PD
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Ambi 40pse/400gfn
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Affected NDC
66870-0408-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- TG United, Inc.
- NDC code
- 66870-0408-01
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-513-2013 · 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 TG United, Inc.
All 2013 recalls
Class II · Moderate risk
ZoDen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Syrup
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Pediatric Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Other wrong potency / content recalls from 2013
All wrong potency / content recalls
Class II · Moderate risk
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
Class II · Moderate risk
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
Class II · Moderate risk
Clonazepam Tablets
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Class III · Low risk
Ciclopirox Shampoo 1%
Subpotent. drug
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