CLASS II Drug recall · Reported 6 Apr 2016 · FDA Enforcement Report
Acetylcysteine 10% Ophth Solution recalled by Walter's Pharmacy
Walter's Pharmacy is recalling Acetylcysteine 10% Ophth Solution, distributed in Pennsylvania. The recall was initiated on 12 Feb 2016 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-0794-2016
- FDA event ID
- 73336
- Recalling firm
- Walter's Pharmacy, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2016
- FDA classified
- 29 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
Timeline
| 12 Feb 2016 | Recall initiated by company | |
| 29 Mar 2016 | Classified by FDA | +46 days |
| 6 Apr 2016 | Published in enforcement report | +8 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
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
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
Where it was distributed
PA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 012116, 012516
Where was it sold?
PA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 73336This product is part of a recall event; the main page for the event is Vancomycin 25mg/mL Solution recalled by Walter's Pharmacy.