CLASS II Drug recall · Reported 27 Jan 2021 · FDA Enforcement Report
Refresh Relieva PF Preservative-Free Lubricant Eye Drops Sterile recalled
Allergan is recalling Refresh Relieva PF Preservative-Free Lubricant Eye Drops Sterile, distributed nationwide in the US. The recall was initiated on 30 Dec 2020 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-0233-2021
- FDA event ID
- 87016
- Recalling firm
- Allergan, Madison, NJ
- Manufacturer
- Allergan, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2020
- FDA classified
- 19 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 30 Dec 2020 | Recall initiated by company | |
| 19 Jan 2021 | Classified by FDA | +20 days |
| 27 Jan 2021 | 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
Labeling: Missing instructions for use insert
Product as listed by the FDA
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Labeling: Missing instructions for use insert
Which lots are affected?
Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
Where was it sold?
Nationwide.
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.
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