Martin Avenue Pharmacy Recalls Tetracycline Powder Kits for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tetracycline 250 mg powder kits due to quality control observations that present a risk to sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk to sterility assurance for a drug product, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Tetracycline 250 mg powder kits. The affected products are packaged with powder and water in separate amber glass vials, with a filter, in a bag. The recall covers 7 kits distributed nationwide.
The recall is being initiated in connection with a recent FDA inspection. Observations associated with certain quality control procedures present a risk to sterility assurance for these compounded sterile preparations. The agency classification for this recall is Class II.
Consumers who have these products should stop using them and contact Martin Avenue Pharmacy, Inc. for further instructions.
The recalled product
- Product
- Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Hazard
- Affected units
- 7
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 (9)
- Lot Number: 07152014@50
- Exp 10/13/2014
- 07152014@54
- 07152014@55
- 07152014@56
- 07152014@48
- 07152014@49
- 08062014@53
- Exp 11/4/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. 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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