Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
GaviLyte -C
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specification
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Affected NDC
43386-0060-19
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| GaviLyte - C TM polyethylene glycol-3350 and electrolytes with Flavor Pack NDC 43386-0060 |
POLYETHYLENE GLYCOL 3350 240 g/278.26g; SODIUM CHLORIDE 5.84 g/278.26g; POTASSIUM CHLORIDE 2.98 g/278.26g; SODIUM BICARBONATE 6.72 g/278.26g; SODIUM SULFATE ANHYDROUS 22.72 g/278.26g | Powder, for Solution Oral |
Lupin Pharmaceuticals,Inc. | Rx |
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 43386-060-19
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0875-2022 · 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 Lupin Pharmaceuticals Inc.
All 2022 recalls
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
Other stability / shelf life recalls from 2022
All stability / shelf life recalls
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class III · Low risk
Fyarro (albumin-bound)
Failed Stability Specifications
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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