Class II recall: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by

AI Summary

The FDA has issued a Class II (voluntary) recall of Levothyroxine Sodium Tablets, USP, 75 mcg manufactured by Intas Pharmaceuticals Limited for Accord Healthcare, Inc., due to subpotency of the active drug. This nationwide recall affects all 1000-count bottles with NDC 16729-449-17 and requires clinicians to reassess thyroid hormone adequacy in patients using this lot.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets for subpotency; affects patients nationwide and requires immediate clinical attention to dosing adequacy.

Study design

As stated by the source record.

Reported figures

Quoted from the source exactly as published.

Clinical bottom line

Clinicians should identify patients prescribed this specific levothyroxine product lot and consider reassessment of thyroid function (TSH, free T4) to determine whether dosing adjustments are necessary. Subpotent tablets may result in inadequate thyroid hormone replacement and recurrence of hypothyroid symptoms or biochemical evidence of hypothyroidism.

Caveats

• This recall notice does not provide the magnitude of subpotency (e.g., actual content percentage or concentration range).
• No clinical outcome data, adverse event reports, or patient impact summary is provided in this regulatory notice.
• Affected batch dates, expiration dates, or production run numbers are not specified in the recall notice.
• The notice does not indicate whether other strengths or manufacturers of levothyroxine are affected.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.