Sun Pharma Recalls Ketorolac Ophthalmic Solution Due to Particulate Matter
Sun Pharma Global Fze is recalling specific bottles of Ketorolac Tromethamine Ophthalmic Solution because the product contains particulate matter exceeding specification limits.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is particulate matter, a quality defect, without reported injuries or illnesses in the source text.
Plain-English summary
Sun Pharma Global Fze is voluntarily recalling 5,322 bottles of Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL. The recall affects Lot #JKM5035A with an expiration date of 07/15. The product is distributed by Caraco Pharmaceutical Laboratories Ltd. and was distributed nationwide and in Puerto Rico.
The recall was initiated because the specific lot does not meet the specification limit for the number of particles present in the solution. The presence of particulate matter in ophthalmic solutions is a quality control failure that may pose a risk to patients using the medication.
Consumers and healthcare providers should stop using the affected product immediately. Patients should consult their healthcare provider for alternative treatment options. The product is prescription-only, so consumers should not attempt to use the medication if they have identified the specific lot number and expiration date.
The recalled product
- Product
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC…
- Manufacturer
- Sun Pharma Global Fze
- Category
- Drug — Ophthalmic Solution
- Affected units
- 5,322
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)
- Lot #: JKM5035A
- Exp 07/15
Distribution
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