American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data
American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves stability data not supporting expiration dates, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder in 1 GM, 5 GM, and 10 GM bottles. The recall is being conducted because stability data from the manufacturer does not support the expiration dates listed on the product.
The affected lots include 071916-1, 080516-1, 080516-2, 101216-1, and 011917C-1. The total quantity involved is 1460 GM. The product was distributed nationwide in the USA.
Consumers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 1,460
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 (8)
- Lots: 071916-1
- Exp. 07/08/2018
- 080516-1
- 080516-2
- Exp. 07/22/2018
- 101216-1
- 011917C-1
- Exp. 09/15/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by American Pharmaceutical Ingredients 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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