Avella Recalls Hydroxyprogesterone Caproate Injectable Due to Crystallization
Avella of Deer Valley, Inc. is recalling 197 vials of Hydroxyprogesterone Caproate 250 mg/mL injectable because crystals were observed in the product.
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) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 197 vials of Hydroxyprogesterone Caproate 250 mg/mL (in sesame oil), Rx Only 4 mL Injectable IM Use. The product was manufactured by Avella Specialty Pharmacy in Phoenix, AZ. The recall was initiated because crystals were observed in the product.
The affected product is distributed nationwide. The specific lots involved are Lot# 12-20140207@109 (Expiration 12/14) and Lot# 12-20142107@82 (Expiration 01/15).
Consumers and healthcare providers should discontinue use of the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
- Manufacturer
- Avella of Deer Valley, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 197
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 (3)
- Lot# 12-20140207@109
- Exp. 12/14 Lot# 12-20142107@82
- Exp. 01/15
Distribution
Distributed nationwide across the United States.
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