Safecor Health Recalls Doxycycline Tablets Due to Manufacturing Deviations
Safecor Health LLC is recalling 856 bottles of Doxycycline 100mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.
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. According to the rubric, FDA Class II recalls with potential for significant injury or property damage, or those involving structural defects or significant reports, are rated as Severe (4). While the specific injury reports are not detailed in the text, the Class II classification for a drug involving CGMP deviations typically warrants a Severe rating under the provided criteria for significant risk.
Plain-English summary
Safecor Health, LLC has voluntarily recalled 856 bottles of Doxycycline 100mg Tablets, 14-count bottles, prescription only. The product is identified by NDC 0143314205, Lot # A25593, and an expiration date of 2/22/2017. The recall was initiated on July 7, 2016, and was classified as Class II by the FDA.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed in Massachusetts and New York. The recall status is currently terminated, with a termination date of July 12, 2017.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement. The recall was initiated by the firm and notified via letter.
The recalled product
- Product
- Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Antibiotic
- Affected units
- 856
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 # A25593
- Exp. 2/22/2017
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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