Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Methylcobalamin 1,000 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or property damage (such as sterility failures in injectables) are rated as Severe (4).
Plain-English summary
The Compounding Pharmacy of America is recalling Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate. The recall involves 1,588 ml of product distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected lots immediately. The specific lot codes and expiration dates are listed in the official recall notice. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- 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 (20)
- All lots distributed between November 2014 and May 2015
- 03022015@86
- 5/31/2015
- 04012015@71
- 6/30/2015
- 02202015@43
- 5/21/2015
- 2232015@74
- 5/24/2015
- 02272015@70
- 5/28/2015
- 03052015@8
- 6/3/2015
- 03102015@61
- 6/8/2015
- 03092015@97
- 6/7/2015
- 03202015@98
- 6/18/2015
- 03232015@62
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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.
See all 382 products in this recall →Related recalls
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