Progesterone Injection Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling specific lots of Progesterone 50 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling 637 ml of Progesterone 50 mg/ml. The recall involves two specific lots: Lot number CABDBFAC:48 with an expiration date of 5/17/2014, and Lot number CABDCEAB:14 with an expiration date of 4/25/2014.
The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes and the assurance of sterility for the product. The agency has classified this recall as Class II.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or the recalling firm for disposal or credit.
The recalled product
- Product
- Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 637
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 (4)
- Lot number CABDBFAC:48
- Exp date: 5/17/2014
- and Lot number CABDCEAB:14
- Exp date: 4/25/2014.
Distribution
Part of a larger recall action
This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy 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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