The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-658-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Ophthalmic Dilation Gel

Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of 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 with potential for significant injury or hospitalization (implied by sterility failure in a medical product) map to a score of 4 (Severe).

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes. Specifically, the agency identified a lack of assurance of sterility in the product.

The recalled product consists of 378ml units of ophthalmic dilation gel. The distribution pattern indicates that the product was shipped to Florida, Georgia, and South Carolina. Specific lot numbers and expiration dates are listed in the official recall documentation.

Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Ophthalmic
Hazard
Affected units
378

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 (20)

  • Lot number CABDBDAC:11
  • Exp date: 8/12/2013
  • Lot number CABCCHAJ:28
  • Exp date: 3/26/2013
  • Lot number CABCBBBA:57
  • Exp date: 4/9/2013
  • Lot number CABCCGBA:11
  • Exp date: 4/24/2013
  • Lot number CABCACBB:26
  • Exp date: 5/1/2013
  • Lot number CABCBGBB:54
  • Exp date: 5/15/2013
  • Lot number CABCCJBB:38
  • Exp date: 5/28/2013
  • Lot number CABCBDBC:40
  • Exp date: 6/11/2013
  • Lot number CABCCIBC:73
  • Exp date: 6/26/2013
  • Lot number CABDBBAB:32
  • Exp date: 7/10/2013

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 →

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