RX3 Pharmacy Recalls Hydroxyprogesterone Caproate Syringes Due to Crystallization
RX South LLC is recalling 250 syringes of Hydroxyprogesterone Caproate 250mg/ml due to visible crystals formed by extreme cold during shipping.
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 physical defect (crystallization) caused by shipping conditions, which fits the criteria for moderate severity involving low-risk contamination or physical defects without reported injuries.
Plain-English summary
RX South LLC DBA RX3 Pharmacy is recalling 250 syringes of Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution. The product is a multi-ingredient compounded medication in bulk that also contains Benzoyl Benzoate USP and Benzyl Alcohol. The syringes are labeled for injection use only.
The recall was initiated because visible crystals from the active ingredient formed due to extreme cold temperatures during shipping. This crystallization is a physical defect in the product.
The product was distributed in Virginia and Maryland. The specific lot number is 12052013:03, with an expiration date of 06/03/2014. Consumers and healthcare providers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION…
- Manufacturer
- RX South LLC DBA RX3 Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 250
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)
- Lot number: 12052013:03 Expiration date: 06/03/2014
Distribution
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