Class I · High risk
Andropharm M1 Alpha
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Andropharm Sten Z
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
- Recalling firm
- Andropharm, LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1142-2017 · 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 recalls by Andropharm, LLC
All 2017 recallsOther unapproved drug recalls from 2017
All unapproved drug recalls
Class III · Low risk
Gabapentin Oral Solution
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Class III · Low risk
Meclizine hydrochloride tablets USP
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class II · Moderate risk
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Marketed Without an Approved NDA/ANDA
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