Perry Drug Recalls Methyl B12 Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 injection due to potential sterility assurance issues identified during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable products.
Plain-English summary
Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 25 mg/mL Injection, compounded by Perry Drug Compounding Pharmacy in Overland Park, Kansas. The recall involves specific lots distributed in Kansas and Missouri, with lot codes and dates ranging from November 6, 2014, to November 30, 2014.
The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy. As a result, all lots of sterile products compounded by the pharmacy that are within their expiration date have been recalled.
Consumers who have purchased these specific syringes should stop using them and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
- Manufacturer
- Perry Drug Inc.
- Category
- Drug — Compounded Injectable
- Affected units
- 186
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 (12)
- 141006GG
- 11/6/14
- 141009FF
- 11/9/14
- 141014BB
- 11/14/14
- 1410164
- 11/16/14
- 141021GG
- 11/21/14
- 141030DD
- 11/30/14
Distribution
Part of a larger recall action
This product is one of 17 recalled by Perry Drug 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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