G&W Laboratories Recalls Indocin Suppositories for Impurity Failures
G&W Laboratories is recalling Indocin suppositories due to out-of-specification impurity results found during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (score 4) under the rubric, particularly given the nature of the impurity failure in a pharmaceutical product.
Plain-English summary
G&W Laboratories, Inc. is recalling Indocin (Indomethacin) suppositories, USP, 50 mg, due to failed impurities and degradation specifications. The recall involves 3,456 boxes of the product, which is distributed within the United States by Iroko Pharmaceuticals, LLC.
The recall was initiated because the product encountered out-of-specification (OOS) results for total impurity and out-of-trend results for known impurities during stability testing. The affected lots are 017600011 (Exp. Jan 2018), 0176000014 (Exp. Aug 2018), and 017600015 (Exp. Sep 2018).
This is a prescription-only medication. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments or replacements.
The recalled product
- Product
- 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
- Manufacturer
- G & W Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,456
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 017600011
- Exp. Jan 2018
- 0176000014
- Exp. Aug 2018
- 017600015
- Exp. Sep 2018
Distribution
Distribution scope not specified by the agency.
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