Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Ergoloid Mesylates
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: during long-term stability 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
Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
Affected NDC
53489-0281-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- NDC code
- 53489-281-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0414-2015 · 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 Mutual Pharmaceutical Company, Inc.
All 2015 recalls
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Other impurity / degradation recalls from 2015
All impurity / degradation recalls
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class III · Low risk
Ranitidine Syrup
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk
Quinapril Tablets USP 5 mg
Failed Impurities/Degradation Specifications; Impurity A
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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