CLASS II Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips recalled
G & W Laboratories is recalling Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips. The recall was initiated on 7 Feb 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0501-2017
- FDA event ID
- 76430
- Recalling firm
- G & W Laboratories, South Plainfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2017
- FDA classified
- 1 Mar 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Feb 2017 | Recall initiated by company | |
| 1 Mar 2017 | Classified by FDA | +22 days |
| 8 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43
Where it was distributed
Within United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Which lots are affected?
Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018
Where was it sold?
Within United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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