Class III · Low risk
Skin Medica Acne System
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Missing instructions for use insert
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
0023-6634-10
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Refresh Relieva Preservative Free Carboxymethylcellulose sodium and Glycerin NDC 00023-6634 |
CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL; GLYCERIN 9 mg/mL | Solution/ Drops Ophthalmic |
Allergan, Inc. | OTC |
- Recalling firm
- Allergan, PLC.
- NDC code
- 0023-6634-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0233-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Allergan, PLC.
All 2020 recalls
Class III · Low risk
Skin Medica Acne Treatment Lotion
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
Class II · Moderate risk
INFed (Iron Dextran Injection USP)
Failed Stability Specification: out of specification for iron content.
Other labeling / mix-up recalls from 2020
All labeling / mix-up recalls
Class III · Low risk
Epinephrine/Lidocaine HCl
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Class III · Low risk
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Labelling: Missing label.
Class III · Low risk
Scandonest 3% Plain
Labeling: Label mix-up
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