Agency classClass IIOur severity:Severe FDA (Drugs)·D-0367-2017·Announced 2017-01-11

Wells Pharmacy Recalls Methylcobalamin Injectable Kits Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Methylcobalamin Injectable kits due to a lack of assurance of sterility. The recall covers kits prepared between February 2016 and September 2016.

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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious health consequences.

Plain-English summary

Wells Pharmacy Network LLC is recalling Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit. The product was compounded by Wells Pharmacy in Ocala, Florida. The recall is being conducted due to a lack of assurance of sterility.

The recall affects 7 kits, with the number of vials per kit varying by prescription. The distribution pattern is nationwide. The recall includes all lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot codes include 04292016@93, 07282016@26, and 09082016@37. Known vial lot codes include 04052016@1, 05262016@32, and 08092016@6.

Consumers should check their inventory for the specific lot codes listed above. If the product matches the recalled description, it should be returned to the pharmacy or disposed of according to local regulations. The FDA has classified this recall as Class II.

The recalled product

Product: Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Injectable
Hazard: sterility
infection
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 (6)

All lot codes of product prepared between 02/22/2016 and 09/14/2016
within expiry. Known kit lot code: 04292016@93
07282016@26
09082016@37. Known vial lot code: 04052016@1
05262016@32
08092016@6.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 97 recalled by Wells Pharmacy Network LLC 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 97 products in this recall →

Same manufacturer · Wells Pharmacy Network LLC

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Same hazard · sterility