US Drug Recall Register

Is Pine recalled?

Yes — there is an active recall. 82 ongoing FDA recalls mention Pine (685 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.

Class II · Moderate risk Terminated

Quad mix

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0130-2015
Class II · Moderate risk Terminated

Quad mix

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0129-2015
Class II · Moderate risk Terminated

Quad mix

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0128-2015
Class II · Moderate risk Terminated

Quad mix 2

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0127-2015
Class II · Moderate risk Terminated

Quad mix

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0126-2015
Class II · Moderate risk Terminated

Quad mix 1

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0125-2015
Class II · Moderate risk Terminated

Pilocarpine

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0121-2015
Class II · Moderate risk Terminated

"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0107-2015
Class II · Moderate risk Terminated

Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0061-2015
Class II · Moderate risk Terminated

Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0060-2015
Class II · Moderate risk Terminated

Atropine sulfate 0.5% opthalmic solution packaged in a squeeze…

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0059-2015
Class II · Moderate risk Terminated

Atropine sulfate 0.01% opthalmic solution packaged in a squeeze…

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0058-2015
Class II · Moderate risk Terminated

Tribenzor Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-116-30 D-1504-2014
Class II · Moderate risk Terminated

Azor Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-113-30 D-1501-2014
Class I · High risk Terminated

Oxcarbazepine Tablets

Reason Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.

American Health Packaging NDC 62584-143-01 D-1590-2014
Class II · Moderate risk Completed

Saluta

Reason Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.

Flawless Beauty LLC D-1318-2014
Class I · High risk Terminated

Atropine Sulfate 0.4 mg/ml Injection

Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Pharmakon Pharmaceuticals D-1568-2014
Class III · Low risk Terminated

Olanzapine Orally Disintegrating Tablets 5 mg

Reason Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

Apotex Corp. NDC 60505-3275-03 D-1609-2014
Class III · Low risk Terminated

Papaverine 60 mg

Reason Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

John W Hollis Inc D-1258-2014
Class II · Moderate risk Terminated

Oxcarbazepine Tablets

Reason Failed Tablet Specifications: Broken Tablets Present.

Caraco Pharmaceutical Laboratories Ltd. NDC 62756-184-88 D-1081-2014
Class II · Moderate risk Terminated

Nifedipine

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.

Greenstone Llc NDC 59762-6692-8 D-737-2014
Class II · Moderate risk Terminated

QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE

Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Specialty Medicine Compounding Pharmacy D-443-2014
Class II · Moderate risk Terminated

Epinephrine Pf Sf*

Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Specialty Medicine Compounding Pharmacy D-419-2014