Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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, CA --- NDC 70360-017-38
Affected NDCs
70360-0017-38
70360-0017-39
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine Category: Eye Drops & Ophthalmic
- Recalling firm
- Leiter's Compounding
- NDC code
- 70360-017-38
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0013-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by Leiter's Compounding
All 2016 recalls
Class II · Moderate risk
Vancomycin 10 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Placebo for Prednisolone Acetate 1%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Mitomycin 0.02%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.