Mutual Pharmaceutical Recalls Ergoloid Mesylates Tablets Due to Impurities
Mutual Pharmaceutical is recalling Ergoloid Mesylates 1 mg tablets because they failed impurity and degradation specifications 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential adverse health consequences from impurities, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
Mutual Pharmaceutical Company, Inc. is recalling Ergoloid Mesylates 1 mg tablets, 100-count bottles, NDC 53489-281-01. The recall involves 23,246 bottles distributed nationwide. The affected lots are 6557301, 6557401, and 6557501 (all expiring 3/15), 6656301 (expiring 10/16), and 6687701 (expiring 4/17).
The recall was initiated because the product failed impurities and degradation specifications during long-term stability testing. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The product is prescription-only and was manufactured by Mutual Pharmaceutical Company, Inc. for Sun Pharmaceutical Industries, Inc.
The recalled product
- Product
- 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
- Manufacturer
- Mutual Pharmaceutical Company, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 23,246
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 (8)
- Lot #: 6557301
- Exp 3/15
- 6557401
- 6557501
- 6656301
- Exp 10/16
- 6687701
- Exp 4/17.
Distribution
Distributed nationwide across the United States.
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