Morton Grove Recalls Amoxicillin and Clavulanate Potassium Oral Suspension
Morton Grove Pharmaceuticals is recalling 7,332 bottles of Amoxicillin and Clavulanate Potassium Oral Suspension due to a customer complaint of a blue nitrile glove fragment found in the product.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a physical foreign object (nitrile glove fragment) in a medication, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling 7,332 bottles of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted). The product is identified by Batch # KH60276 and an expiration date of 10/18. The medication was manufactured by Cipla Ltd. at Medispray Laboratories Pvt. Ltd. in India for Wockhardt USA, LLC.
The recall was initiated following a customer complaint identifying a blue foreign material in the product, which was determined to be a portion of a nitrile glove. The affected product was distributed nationwide in the USA and Puerto Rico.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054…
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Affected units
- 7,332
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 (2)
- Batch #: KH60276
- Exp 10/18
Distribution
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