CLASS II Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder recalled
Pharmacy Plus is recalling Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402, distributed in Mississippi. The recall was initiated on 26 Jul 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-1541-2016
- FDA event ID
- 75164
- Recalling firm
- Pharmacy Plus, Hattiesburg, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2016
- FDA classified
- 27 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jul 2016 | Recall initiated by company | |
| 27 Sep 2016 | Classified by FDA | +63 days |
| 5 Oct 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
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Where it was distributed
MS
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot#: 390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16
Where was it sold?
MS
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
20 other products · FDA event 75164This product is part of a recall event; the main page for the event is Hyaluronidase, 150 u/ml SDV, Vital Care Compounder recalled.
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|---|---|---|---|---|---|
| Drug | CLASS II | C-Semaglutide 5mg/mL injection vials recalled by Pharmacy Plus | Pharmacy Plus | Sterility | MS |
| Drug | CLASS II | Mitomycin Injection 0.375 mg/mL Syr, 0.375 mg/mL solution syringe recalled | Pharmacy Plus | Sterility | 4 states |
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| Drug | CLASS II | Cyclosporin 0.07% Opth 0.07% Solution recalled by Pharmacy Plus | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Prostaglandin E1 Injection Solution 500MCG/ML Solution vials recalled | Pharmacy Plus | Sterility | 4 states |