Class II · Moderate risk
Sodium Phenylbutyrate POWDER
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Sodium Phenylbutyrate Powder
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
Affected NDC
42794-0086-14
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- SigmaPharm Laboratories LLC
- NDC code
- 42794-086-14
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0898-2021 · 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 SigmaPharm Laboratories LLC
All 2021 recalls
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class II · Moderate risk
Liothyronine Sodium Tablets
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Other impurity / degradation recalls from 2021
All impurity / degradation recalls
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class III · Low risk
Carvedilol Tablets
Failed Impurities/Degradation Specifications
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