The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0512-2016·Announced 2015-12-16

RemedyRepack Recalls Bicillin L-A Due to Incorrect Storage Instructions

RemedyRepack, Inc. is recalling 60 vials of Bicillin L-A 600,000 Units/mL injection because the product labels contain incorrect storage instructions.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to incorrect storage instructions, which is a labeling error that may lead to temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria.

Plain-English summary

RemedyRepack, Inc. is recalling 60 vials of Bicillin L-A 600,000 Units/mL Injection, NDC 61786-0253-03. The product was manufactured by King Pharma Inc. and repackaged by RemedyRepack, Inc. The recall is limited to specific lots: B0077329-040215 (Exp 07/2017), B0091342-070315 (Exp 08/2017), and B0109416-102815 (Exp 03/2018).

The recall was initiated because the product labels contain incorrect storage instructions. The FDA has classified this as a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03
Manufacturer
RemedyRepack Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
60

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)

  • Lot # B0077329-040215
  • Exp 07/2017
  • B0091342-070315
  • Exp 08/2017
  • B0109416-102815
  • Exp 03/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by RemedyRepack 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.

See all 7 products in this recall →

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