Reliable Compounding Pharmacy Recalls Minocycline Products Due to Processing Controls
Reliable Compounding Pharmacy is recalling all minocycline products compounded between March 2015 and March 2016 due to a lack of processing controls.
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 agency classified this recall as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Reliable Rexall-A Compounding Pharmacy is recalling all minocycline products, prescription only, that were compounded by the facility located at 801 Irving St., San Francisco, CA 94122. The recall covers all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates.
The recall was initiated due to a lack of processing controls. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed in the United States, including California, Hawaii, and New Mexico. Consumers who have these products should stop using them and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
- Manufacturer
- Reliable Rexall-A Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- Hazard
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 (1)
- All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.
Distribution
Part of a larger recall action
This product is one of 70 recalled by Reliable Rexall-A Compounding Pharmacy 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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