Safecor Health Recalls Acetaminophen Tablets Due to Manufacturing Deviations
Safecor Health is recalling 66 bottles of Acetaminophen 325mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed in Massachusetts and New York.
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 typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The source cites CGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for voluntary precautionary measures.
Plain-English summary
Safecor Health, LLC has voluntarily recalled 66 bottles of Acetaminophen 325mg tablets, 120-count bottles. The recall was initiated on July 7, 2016, and was classified as Class II by the FDA. The specific product is identified by NDC 00904198280, Lot # A18688, and an expiration date of 09/30/2018.
The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed in Massachusetts and New York. The recall was initiated by the firm and was terminated on July 12, 2017.
Consumers who have this specific lot of Acetaminophen tablets should stop using them and contact Safecor Health or their healthcare provider for further instructions. The recall status is currently terminated.
The recalled product
- Product
- Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
- Manufacturer
- Safecor Health, LLC
- Hazard
- Affected units
- 66
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 #: A18688
- Exp. 09/30/2018
Distribution
Part of a larger recall action
This product is one of 6 recalled by Safecor Health, LLC 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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