The Recall Desk
SevereFDA (Drugs)·D-644-2013·Announced 2013-07-10

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.

What this means for you

Illness, injury, or structural failure has been reported. 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

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

Distributed in 3 states:

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.

See all 49 products in this recall →