The Recall Desk
SevereFDA (Drugs)·D-680-2013·Announced 2013-07-10

Vancomycin Recall Due to Sterility Concerns at Compounding Pharmacy

Clinical Specialties Compounding Pharmacy is recalling Vancomycin 50 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Vancomycin 50 mg/ml, 20ml total, due to concerns regarding quality control processes and assurance of sterility. The recall was initiated following FDA inspection findings.

The affected product is identified by Lot number CABDCCAC:54 with an expiration date of 3/24/2013. The product was distributed in Florida, Georgia, and South Carolina.

Consumers and healthcare providers should stop using the recalled product and contact the pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Affected units
20

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 (2)

  • Lot number CABDCCAC:54
  • Exp date: 3/24/2013.

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 →