Apothecary Shoppe Recalls Hydroxyprogesterone Caproate Vials for Sterility Concerns
The Apothecary Shoppe is recalling Hydroxyprogesterone Caproate 250 vials due to lack of documentation for environmental monitoring during production.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 is a documentation issue regarding environmental monitoring rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Apothecary Shoppe LLC is recalling SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vials. The recall involves 34 mL of product distributed in Oklahoma. The specific lot number is 04222015@20, with a beyond-use date of 08/30/2015.
The recall was initiated due to a lack of assurance of sterility. This was caused by a lack of documentation regarding proper environmental monitoring during the time the medication was produced.
Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
- Manufacturer
- The Apothecary Shoppe LLC
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 (2)
- Lot #: 04222015@20
- BUD 08/30/2015
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 28 recalled by The Apothecary Shoppe 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 28 products in this recall →Related recalls
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