CLASS II Drug recall · Reported 6 Apr 2016 · FDA Enforcement Report
Vancomycin 50mg/mL Solution recalled by Walter's Pharmacy
Walter's Pharmacy is recalling Vancomycin 50mg/mL 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-0797-2016
- 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
- Drug class
- Antibiotics
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
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Where it was distributed
PA
Questions about this recall
Is Vancomycin 50mg/mL Solution recalled?
Yes. Walter's Pharmacy recalled Vancomycin 50mg/mL Solution on 12 Feb 2016. The recall is Class II and its status is Terminated. Recall number D-0797-2016.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 020216
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 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.