FDA Recalls Estrastain Pro-Anabolic Mass and Hardening Complex Capsules
Anabolic Science Labs LLC is recalling Estrastain Pro-Anabolic Mass and Hardening Complex capsules because they contain unapproved synthetic hormone ingredients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Anabolic Science Labs, LLC is recalling Estrastain Pro-Anabolic Mass and Hardening Complex capsules. The product is manufactured for Wyked Labs LLC and contains Estra-4,9,11-triene-3,17-dione and 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol. The recall involves 12,166 bottles of 60-count capsules.
The FDA is recalling these products because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall is due to the presence of synthetic hormone and prohormone ingredients, specifically methylated anabolic steroids, which makes them unapproved new drugs.
The affected products were distributed nationwide in the United States and in Singapore. Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
- Manufacturer
- Anabolic Science Labs, LLC
- Category
- Drug — Unapproved New Drug
- Affected units
- 12,166
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Anabolic Science Labs, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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