CLASS II Drug recall · Reported 22 Jan 2014 · FDA Enforcement Report
Phenylephrine/Tropicamide 5 %/1 % ophthalmic solution recalled
Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide 5 %/1 % ophthalmic solution, distributed in Michigan. The recall was initiated on 19 Oct 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-439-2014
- FDA event ID
- 66566
- Recalling firm
- Specialty Medicine Compounding Pharmacy, South Lyon, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2013
- FDA classified
- 10 Jan 2014
- Reported
- 22 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 19 Oct 2013 | Recall initiated by company | |
| 10 Jan 2014 | Classified by FDA | +83 days |
| 22 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Where it was distributed
Hospitals, clinics, physicians, and patients in the Michigan area only.
Questions about this recall
Is Phenylephrine/Tropicamide 5 %/1 % ophthalmic solution recalled?
Yes. Specialty Medicine Compounding Pharmacy recalled Phenylephrine/Tropicamide 5 %/1 % ophthalmic solution on 19 Oct 2013. The recall is Class II and its status is Terminated. Recall number D-439-2014.
Why was it recalled?
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Which lots are affected?
All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@6
Where was it sold?
Hospitals, clinics, physicians, and patients in the Michigan area only.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.