Class I · High risk
Thyroid Tablets
Superpotent Drug
NP Thyroid 15 (Levothyroxine, Liothyronine)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
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
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
Affected NDC
42192-0327-01
Compare with the code on your package — it is the most precise check available.
Drug: Thyroid Category: Thyroid Medication
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 |
|---|---|---|---|---|
| NP Thyroid 15 Levothyroxine, Liothyronine NDC 42192-0327 |
LIOTHYRONINE 2.25 ug/1; LEVOTHYROXINE 9.5 ug/1 | Tablet Oral |
Acella Pharmaceuticals, LLC | Rx |
- Recalling firm
- Acella Pharmaceuticals, LLC
- NDC code
- 42192-327-01
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0035-2021 · 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 Thyroid recalls
See all
Class II · Moderate risk
Thyroid
Subpotent Drug
Class II · Moderate risk
S.P Labs
Failed Stability Specifications
Class II · Moderate risk
S.P.Labs
Failed Stability Specifications
Class II · Moderate risk
Levothyroxine 25mcg in Ns 1.25ml Syringe
Lack of sterility assurance
Other recalls by Acella Pharmaceuticals, LLC
All 2020 recalls
Class II · Moderate risk
Naproxen Oral Suspension
Chemical contamination; presence of lead and lithium above specification
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
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