Cyanocobalamin Injection Vials Recalled for Glass Particulate Contamination
Zydus Pharmaceuticals recalls 432,250 vials of Cyanocobalamin Injection USP due to glass particulate matter. Affected vials are distributed in Tennessee.
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 3/5 (High).
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: FDA Class II recall of injectable medication containing glass particulate matter. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for Score 3 (High).
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Cyanocobalamin Injection, USP 1,000 mcg/mL, in 1 mL multiple-dose vials due to the presence of glass particulate matter in the product. The recall affects 432,250 vials distributed in Tennessee.
The affected product is identified by NDC number 16714-165-01 with lot numbers L200253, L200281, and L200301, with expiration date July 31, 2024. The product is manufactured in India and distributed under the Northstar Rx LLC label (Memphis, TN).
Consumers and healthcare providers in possession of the affected product should verify their supplies against the recalled lot numbers.
The recalled product
- Product
- Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 432,250
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 (4)
- Lot #: L200253
- L200281
- L200301
- Exp 07/31/2024
Distribution
Distributed in 1 state:
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