Exela Pharma Recalls Diclofenac and Misoprostol Tablets Due to Labeling Error
Exela Pharma Sciences LLC is recalling 5,256 bottles of Diclofenac Sodium and Misoprostol tablets because some bottles were mislabeled with the wrong dosage.
What this means for you
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 due to a labeling error involving dosage mismatch, which fits the rubric criteria for minor labeling errors and low-risk contamination.
Plain-English summary
Exela Pharma Sciences LLC is recalling 5,256 bottles of Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg. The recall was initiated due to a labeling error where bottles labeled as containing the 75 mg/0.2 mg dosage actually contained 50 mg/0.2 mg tablets.
The affected product is identified by Lot GH70154 with an expiration date of 12/18. The product was distributed nationwide in the USA and Puerto Rico. The tablets are prescription-only and were manufactured by Cipla Ltd. in India for Eagle Pharmaceuticals, Inc.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,256
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: GH70154
- Exp 12/18
Distribution
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