Clinical Specialties Compounding Pharmacy Recalls HCG Syringes Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling HCG 2000 units/ml syringes because FDA inspection findings raised concerns about quality control and assurance of sterility.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance issues in injectable drugs are categorized as Severe (Score 4), particularly when structural or quality control defects are identified by the agency.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling HCG 2000 units/ml, 30 mL syringes. The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes and the assurance of sterility for the product.
The affected product includes two specific lots: Lot number CABDAJAB:54 with an expiration date of 3/10/2013, and Lot number CABDABAC:38 with an expiration date of 5/31/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable
- Hazard
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 number CABDAJAB:54
- Exp date: 3/10/2013 and Lot number CABDABAC:38
- Exp date: 5/31/2013.
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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