Contract Pharmacal Recalls Leader Extra Strength Acetaminophen Tablets
Contract Pharmacal is recalling Leader Extra Strength Acetaminophen tablets due to a complaint about a foreign prenatal tablet found in the bottle.
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, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (such as ingestion of a foreign substance) are rated as Severe.
Plain-English summary
Contract Pharmacal Corporation is recalling 5,472 bottles of Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, 100-count bottles. The product is distributed by Cardinal Health in Dublin, Ohio, and was distributed nationwide within the United States. The specific lot number is 193005 with an expiration date of 08/21.
The recall was initiated due to a complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents. This is classified as an FDA Class II recall.
Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8
- Manufacturer
- Contract Pharmacal Corporation
- Affected units
- 5,472
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 #: 193005
- Exp. Date 08/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Contract Pharmacal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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