Class III · Low risk
Peg-3350
Defective container: potential for non-sealed pouches which can lead to product leakage.
GaviLyteTM - C PEG-3350
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specification; Out of specification for Osmolarity
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
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 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
- Novel Laboratories, Inc. d.b.a LUPIN
- NDC code
- 43386-060-19
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0726-2021 · 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 Novel Laboratories, Inc. d.b.a LUPIN
All 2021 recalls
Class III · Low risk
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Other stability / shelf life recalls from 2021
All stability / shelf life recalls
Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II · Moderate risk
Pain Aid Esf-
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class III · Low risk
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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