FDA Recalls Ketamine HCl USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Ketamine HCl USP for prescription compounding due to a lack of stability data supporting 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a documentation and stability data issue rather than a direct contamination or acute injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Ketamine HCl USP for prescription compounding, manufactured by American Pharmaceutical Ingredients LLC. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system.
Healthcare professionals and pharmacies should discontinue use of the affected lots and return them to the manufacturer. Consumers should not use the product and should contact their healthcare provider for guidance.
The recalled product
- Product
- Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 191,000
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 (14)
- Lot #: a) 102015-3
- Exp. 07/31/2020
- 081616-3R
- Exp. 02/28/2021
- b) 081616-3
- 102015-2
- c) 081616-1R
- 081616-1
- Exp. 02/29/2021
- 102015-1
- d) 102015-1
- 081616-1R
- 081616-2R
- Exp. 02/28/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 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.
See all 66 products in this recall →Related recalls
Same manufacturer · American Pharmaceutical Ingredients LLC
See all →- ModerateAmerican Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data
FDA (Drugs) · 2018-03-21
- ModerateOxytocin USP Powder Recalled Due to Insufficient Stability Data
FDA (Drugs) · 2018-03-21
- ModerateFDA Recalls Testosterone Cypionate Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
- ModerateLevofloxacin Hemihydrate Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
- ModerateFDA Recalls Doxycycline Hyclate Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
Same hazard · stability data deficiency
See all →- ModerateFDA Recalls Tramadol HCl for Prescription Compounding Due to Stability Data Deficiencies
FDA (Drugs) · 2018-02-28
- ModerateAmerican Pharmaceutical Ingredients Recalls Anastrozole USP Due to Stability Data Deficiencies
FDA (Drugs) · 2018-02-28
- ModerateFDA Recalls Calcipotriene BP Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
- ModerateBaclofen USP Micronized Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
- ModerateKetoconazole USP Recalled for Lack of Stability Data and Controls
FDA (Drugs) · 2018-02-28