The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0013-2017·Announced 2016-10-19

Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns

Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a 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 and involves a lack of assurance of sterility in an ophthalmic solution, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

Leiter's Compounding, located in San Jose, California, is recalling Cyclopentolate HCl 1% - Tropicamide 1% - Phenylephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution). The recall involves products in 1 mL and 10 mL total volumes packaged in 15 mL dropper bottles. The specific NDC numbers are 70360-017-38 and 70360-017-39.

The recall was initiated due to a lack of assurance of sterility. All compounded products within their expiration dates were produced using filters that are subject to a separate recall. The affected units include all unexpired lots with expiration dates ranging from 10/03/2016 to 11/06/2016 for the 1 mL volume and 09/25/2016 to 10/01/2016 for the 10 mL volume. A total of 76,315 units were distributed nationwide.

Consumers and healthcare providers should stop using the recalled ophthalmic solution and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
Manufacturer
Leiter's Compounding
Category
Drug — Ophthalmic Solution
Hazard
Affected units
76,315

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)

  • All unexpired lots
  • a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Leiter's Compounding 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 9 products in this recall →

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