Class II · Moderate risk
Polidocanol 1% Solution for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Phosphatidylcholine Solution for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
- Recalling firm
- John W Hollis Inc
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1257-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by John W Hollis Inc
All 2014 recalls
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Lipotropic Gold
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Other labeling / mix-up recalls from 2014
All labeling / mix-up recalls
Class III · Low risk
3M ESPE Clinpro 5000
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Class II · Moderate risk
J-TAN D PD Drops
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Class III · Low risk
BELVIQ¿ (Lorcaserin HCl)
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
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